Contamination in the Concentrate: An Expert Analysis of Apple Juice Recalls and Food Safety Vulnerabilities in Global Markets

Executive Summary

This report provides an exhaustive analysis of recent apple juice recalls across key English-speaking markets, including the United States, Canada, the United Kingdom, and Australia.

A series of significant food safety incidents between 2023 and 2025 has exposed critical vulnerabilities in the global apple juice supply chain, primarily centered on contamination with inorganic arsenic, the mycotoxin patulin, and foreign materials.

In the United States, two major events define the recent landscape.

A widespread recall initiated in August 2024 by Refresco Beverages US Inc. eventually encompassed over 133,500 cases of apple juice sold under at least nine major retail store brands, including Walmart’s Great Value and Aldi’s Nature’s Nectar.

The recall was triggered by levels of inorganic arsenic that exceeded the U.S. Food and Drug Administration’s (FDA) non-binding action level.

Concurrently, a 2025 recall by the well-established S.

Martinelli & Company involved over 173,000 bottles contaminated with patulin, a toxin produced by mold.

These incidents highlight a systemic risk embedded in the modern food system: the consolidation of manufacturing in the hands of large, often publicly unknown, co-packing companies.

Refresco, the manufacturer behind both the U.S. arsenic recall and a separate 2023 recall in the United Kingdom for metal fragments in juice straws, serves as a prime example.

A single point of failure within such a large-scale producer can trigger a cascade of multi-brand, international recalls, undermining consumer trust in the retail brands themselves.

The analysis further reveals a significant divergence in regulatory philosophies.

The U.S. system, which relies heavily on industry self-policing against non-enforceable “action levels,” appears largely reactive, with regulatory standards often finalized only after sustained public and consumer advocacy pressure.

This contrasts sharply with the proactive, survey-based approach of agencies like Food Standards Australia New Zealand (FSANZ), which conducts national surveillance to assess contaminant levels and inform risk management strategies before widespread market incidents occur.

Canada and the European Union, meanwhile, utilize legally binding Maximum Levels (MLs) that align with international standards, offering a clearer enforcement framework.

This report details the specifics of each major recall, provides a toxicological profile of the key contaminants, compares the international regulatory frameworks, and examines the historical context of food safety advocacy.

It concludes with a series of actionable recommendations for regulators, industry stakeholders, and consumers aimed at enhancing the safety, transparency, and resilience of the global apple juice supply chain.

Section I: Overview of Recent Major Apple Juice Recalls (2023-2025)

The global apple juice market, a staple in households worldwide, relies on a complex and often opaque supply chain.

A significant portion of the apple juice consumed is produced from concentrate, which is sourced internationally, creating multiple points where contamination can occur—from the orchard to the final packaging.

In recent years, a series of high-profile recalls across North America, the United Kingdom, and other English-speaking nations has brought the safety of this ubiquitous product into sharp focus.

These incidents, driven by a range of contaminants from heavy metals to mycotoxins and manufacturing debris, reveal shared vulnerabilities and divergent regulatory responses that shape the landscape of consumer food safety.

Summary of Key Incidents

The period from 2023 to 2025 was marked by several significant apple juice recalls that serve as case studies for the primary food safety challenges facing the industry.

In the United States, the food safety narrative was dominated by two distinct events.

The first was a large-scale, multi-brand recall initiated in August 2024 by manufacturer Refresco Beverages US Inc. Initially affecting only Walmart’s “Great Value” brand, the recall expanded dramatically to include numerous other major retailers due to contamination with inorganic arsenic.¹

This incident underscored the systemic risks associated with consolidated, third-party manufacturing.

The second major event was a recall by S.

Martinelli & Co. in early 2025 for potential contamination with patulin, a mycotoxin.³

This case highlighted a different type of agricultural contaminant and involved a legacy brand, contrasting with the store-brand focus of the Refresco recall.

In the United Kingdom, a notable recall also involved the same parent company, Refresco.

In late 2023, Refresco Beverages UK Limited recalled various juice products sold under the Asda and Calypso brands.⁴

However, the cause was not an agricultural contaminant but a manufacturing process failure: the potential presence of metal fragments in the straws accompanying the juice boxes.⁶

This incident demonstrated that safety risks extend beyond the raw ingredients to the final packaging stages.

In Canada, the Canadian Food Inspection Agency (CFIA) oversaw a national recall in 2022 of Eden brand Organic Apple Juice, also due to patulin contamination.⁸

This action aligns with a history of CFIA interventions for various hazards, including mold and bacterial risks in other juice and baby food products, showcasing a consistent regulatory oversight process.⁹

Finally, the regulatory bodies in Australia and New Zealand present a different model.

While Food Standards Australia New Zealand (FSANZ) has managed recalls for elevated patulin levels in the past, notably in 2020 ¹¹, its more recent focus has been on proactive surveillance.

National surveys conducted in 2021-2022 to assess the prevalence of patulin and heavy metals like arsenic in the food supply found that levels were generally low and did not pose a significant risk to public health.¹²

This data-driven, survey-first approach offers a distinct contrast to the incident-driven recall actions seen in the U.S. and other markets, forming a key point of comparison for evaluating the effectiveness of different food safety strategies.

Section II: The Refresco Beverages Recall (USA, 2024): A Case Study in Inorganic Arsenic Contamination

The most extensive and complex apple juice recall in the United States in recent years began in the summer of 2024, originating from a single manufacturer but ultimately impacting the supply chains of many of the nation’s largest retailers.

This incident serves as a powerful case study in the vulnerabilities of a consolidated food system, the nuances of regulatory enforcement, and the specific health risks associated with inorganic arsenic contamination in fruit juices.

Initial Recall and Expansion

The recall was initiated voluntarily on August 15, 2024, by Refresco Beverages US Inc., a Tampa, Florida-based company.¹

The initial action was limited in scope, covering approximately 9,500 cases of Walmart’s private-label “Great Value” brand 100% Apple Juice, specifically the six-packs of 8-ounce plastic bottles.²

The recall was triggered after the product was found to contain levels of inorganic arsenic that exceeded the industry guidance level set by the U.S. Food and Drug Administration (FDA).¹⁴

In September 2024, the situation escalated dramatically.

The recall was expanded to include an additional 132,000 cases, bringing the total to over 133,500 cases of apple juice.¹

This expansion revealed the vast reach of Refresco Beverages as a contract manufacturer, or “co-packer,” for numerous prominent store brands.

The updated recall list included products sold at major supermarket and pharmacy chains, such as Aldi, BJ’s Wholesale Club, Dollar General, Walgreens, Weis Markets, Market Basket, Key Food, and Lidl.¹

The recall now encompassed not only the initial 8-ounce six-packs but also larger 64-ounce and 96-ounce bottles sold under various brand names like “Nature’s Nectar,” “Nice!,” “Clover Valley,” and “Wellsley Farms”.¹

FDA Classification and Risk Assessment

On August 23, 2024, the FDA assigned the initial recall a Class II risk classification.¹

This classification is defined as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”.³

This designation indicates that while the product was in violation of safety guidelines, the agency did not anticipate severe or irreversible medical outcomes for consumers.¹

The specific level of contamination detected in the juice was 13.2 parts per billion (ppb) of inorganic arsenic.¹⁵

This amount is slightly above the FDA’s non-binding “action level” of 10 ppb for inorganic arsenic in apple juice, a guidance figure established in June 2023 to encourage manufacturers to minimize contamination.²

Despite the recall’s wide scope, the FDA stated that it had not received any reports of illness associated with the consumption of the affected products.¹

In a statement, a Walmart spokesperson affirmed the company’s commitment to customer safety and noted that the product had been removed from impacted stores while an investigation with the supplier was underway.²

Table 2.1: Comprehensive List of Products in the Refresco Beverages US Inc. Arsenic Recall

The following table consolidates information from multiple public announcements to provide a comprehensive list of all products included in the expanded recall initiated by Refresco Beverages US Inc. due to elevated levels of inorganic arsenic.

Retailer	Brand Name	Product Description	Size	UPC	Best By / Sell By Dates	States of Distribution
Walmart	Great Value	100% Apple Juice	6-pack of 8 oz bottles	0-78742-29655-5	DEC 26, 2024; DEC 27, 2024; DEC 28, 2024	AL, CT, DC, DE, FL, GA, IL, IN, KY, MA, MD, ME, MI, MS, NC, NH, NJ, NY, OH, PA, PR, RI, SC, TN, VA, VT, WV 1
Walmart	Great Value	100% Apple Juice	96 oz bottle	Not specified	DEC 26, 2024; DEC 27, 2024; DEC 28, 2024	IN, OH, ME, NY, PA, PR, VA 1
Aldi	Nature’s Nectar	100% Apple Juice	64 oz bottle	4099100036381	MAR 26, 2025; MAR 27, 2025	AL, FL, GA, IL, IN, IA, KY, MD, MI, NY, NC, OH, PA, SC, WV, WI 1
Walgreens	Nice!	100% Apple Juice	64 oz bottle	Not specified	MAR 25, 2025	FL, GA, OH, PA, WI 1
BJ’s Wholesale Club	Wellsley Farms	100% Apple Juice	96 oz bottle	Not specified	MAR 26, 2025	FL, MA, NJ 1
Dollar General	Clover Valley	100% Apple Juice	64 oz bottle	Not specified	MAR 27, 2025	FL, GA, IN, KY, NY, OH, SC 1
Weis Markets	Weis	100% Apple Juice	64 oz bottle	Not specified	MAR 25, 2025	PA, MD 1
Market Basket	Market Basket	100% Apple Juice from Concentrate	64 oz bottle	Not specified	MAR 25, 2025	ME 1
Key Food	Urban Meadow	100% Apple Juice	64 oz bottle	Not specified	MAR 26, 2025	PA 1
Lidl	Solevita	100% Apple Juice	64 oz bottle	Not specified	MAR 27, 2025	VA 1

The “Co-Packer” Vulnerability

The Refresco recall serves as a stark illustration of a systemic vulnerability within the modern food supply chain: the reliance on large-scale, third-party contract manufacturers, or “co-packers.” Consumers purchase products based on the reputation and branding of the retailer, such as Walmart’s Great Value or Aldi’s Nature’s Nectar, often assuming that these retailers directly control the production process.

However, as this incident demonstrates, a single manufacturer—in this case, Refresco Beverages US Inc.—can be responsible for producing ostensibly competing products for numerous different retail chains.¹

This model of consolidated manufacturing creates a significant potential for widespread, multi-brand food safety failures.

A single contamination event, process control failure, or raw material issue at one manufacturing facility can simultaneously impact dozens of product lines distributed across the country under different labels.

This structure makes traceability more complex and magnifies the scale of any recall.

The fact that the same parent company, Refresco, was also at the center of a major recall in the United Kingdom for an entirely different reason—metal fragments in straws—within the same year suggests that quality control challenges can be systemic within these large manufacturing networks, spanning both raw material sourcing and factory-floor processes.⁴

This centralization of production, while economically efficient, concentrates risk and reduces the transparency of the supply chain for both consumers and, at times, the retailers themselves.

Section III: The S. Martinelli & Co. Recall (USA, 2025): Patulin Mycotoxin Contamination

In contrast to the multi-brand, store-brand-focused recall for inorganic arsenic, a separate incident in early 2025 involved a well-known national brand and a different type of contaminant.

The recall of S.

Martinelli & Company’s apple juice due to potential patulin contamination highlights the persistent risks associated with mycotoxins in fruit-based products and demonstrates how even established companies with long histories can face food safety challenges.

Recall Details and Scope

On March 18, 2025, S.

Martinelli & Company, a California-based beverage company known for its sparkling cider and glass-bottled juices since 1868, initiated a voluntary recall of a specific lot of its apple juice.²²

The recall was substantial, covering 7,234 cases, which amounted to a total of 173,616 individual 10-ounce glass bottles.³

The affected product had been distributed widely across the United States, reaching stores in 28 states.³

The contamination was discovered during routine quality assurance testing conducted by the company, which detected elevated levels of patulin.²³

Contaminant and Classification

The reason for the recall was the potential presence of patulin, a mycotoxin.

Mycotoxins are toxic substances produced naturally by certain types of molds.³

In apples, patulin is primarily produced by the fungus

Penicillium expansum, which causes the fruit to rot and decay.²⁷

The use of moldy, damaged, or improperly stored apples in juice production can lead to the contamination of the final product.¹²

A critical characteristic of patulin is that it is heat-stable, meaning that standard pasteurization processes do not destroy the toxin if it is already present in the fruit.¹²

Following the company’s voluntary action, the FDA reviewed the case and, on April 22, 2025, reclassified the recall as a Class II event.³

This is the same classification used in the Refresco arsenic recall, indicating a situation where exposure may cause “temporary or medically reversible adverse health consequences” but where the probability of serious harm is considered remote.³

As of the recall announcement, no illnesses had been reported in connection with the consumption of the affected juice.³

Table 3.1: Product Identification for the S. Martinelli & Co. Patulin Recall

The following table provides the specific identifying information for the apple juice products included in the recall.

Consumers were advised to check their products against these details.

Product Name	Size	UPC	Best-By Date	States of Distribution
Martinelli’s Apple Juice	10-ounce glass bottles (sold in 4-packs)	0 41244 04102 2	December 5, 2026	AL, AR, AZ, CA, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MI, MO, MS, NC, NH, NJ, NY, OH, PA, SC, TX, UT, VA, WI 3

Section IV: International Recall Landscape: A Comparative Analysis

An examination of apple juice recalls beyond the United States reveals a varied landscape of contaminants, regulatory actions, and public health philosophies.

Incidents in Canada, the United Kingdom, and the regulatory posture in Australia and New Zealand provide valuable context for understanding global food safety challenges and the different strategies employed to mitigate them.

Canada (Canadian Food Inspection Agency – CFIA)

The Canadian Food Inspection Agency (CFIA) actively monitors the food supply and issues recalls for various hazards.

In September 2022, the CFIA issued a recall for Eden brand Organic Apple Juice due to contamination with patulin.⁸

The recall was classified as Class 2, indicating a moderate risk, and the affected product had been sold nationally.⁸

This incident demonstrates that mycotoxin contamination is a concern in both conventional and organic supply chains.

Historically, the CFIA has addressed other contamination issues in apple-based products.

In April 2017, a notice was issued for the recall of Heinz brand Apple Juice from Concentrate due to the presence of mold.⁹

A more severe risk was identified in a February 2017 recall of

PC Organics brand baby food pouches, including several apple-based varieties.

This recall was triggered by a manufacturing error that resulted in excess water in the product, creating a potential risk for the growth of Clostridium botulinum, the bacterium that causes botulism.¹⁰

The FDA posted the CFIA’s notice to alert U.S. consumers who may have purchased the products in Canada, highlighting the cross-border nature of food safety information sharing.¹⁰

United Kingdom (Food Standards Agency – FSA)

In late 2023, the UK’s Food Standards Agency (FSA) issued a recall notice for several juice products manufactured by Refresco Beverages UK Limited, the same parent company involved in the major U.S. arsenic recall.⁴

The recall affected multiple products sold under the

Asda (a major supermarket chain) and Calypso brands, including “Asda 100% Pure Apple Juice From Concentrate” and “Calypso Apple Juice”.⁶

This incident is particularly instructive because the cause of the recall was fundamentally different from the agricultural contaminants seen in the U.S. and Canadian cases.

The recall was initiated due to the potential for metal contamination in the straws attached to the juice boxes, rendering the products unsafe.⁴

This highlights a distinct category of risk: process-based contamination originating from the manufacturing or packaging line, rather than from the raw agricultural ingredients.

The fact that the same global beverage manufacturer, Refresco, experienced a major raw material contamination issue (arsenic) in its U.S. operations and a significant packaging contamination issue (metal fragments) in its U.K. operations within a year suggests that quality control vulnerabilities can exist at multiple, distinct points in a large-scale production system.

It indicates that ensuring food safety requires rigorous oversight of not only ingredient sourcing but also every step of the physical manufacturing and packaging process.

Australia & New Zealand (Food Standards Australia New Zealand – FSANZ)

The approach in Australia and New Zealand offers a notable contrast to the reactive, incident-driven recalls that characterize the U.S. landscape.

While FSANZ has overseen apple juice recalls, such as several in 2020 due to elevated patulin levels ¹¹, the agency’s recent work has emphasized proactive surveillance and data collection to inform its regulatory strategy.

Between 2021 and 2022, FSANZ coordinated a comprehensive national survey to measure patulin levels in 299 apple products, the majority of which were apple juices.¹¹

The survey found that while patulin was detectable in 65% of samples, the concentrations were generally low.¹²

Nearly 90% of apple juice products had patulin levels below the 50

µg/kg (50 ppb) maximum level set by the international food standards body, Codex Alimentarius.¹²

Based on a dietary exposure assessment, FSANZ concluded that there were

no immediate food safety concerns associated with patulin and therefore no current need to introduce specific regulatory limits in the Food Standards Code.¹¹

Similarly, FSANZ conducted a survey on heavy metals, including arsenic and lead, using the same samples collected for the patulin study.¹³

The results, published in March 2025, found that metal concentrations were very low.

Inorganic arsenic was not detected in any samples, and all detected metal levels were below existing Australian and international regulatory limits.

Again, FSANZ concluded there were no public health and safety concerns for Australian consumers based on this data.¹³

This “survey-first” regulatory model represents a different public health philosophy.

Instead of relying primarily on industry self-regulation against guidance levels and reacting with recalls when those levels are exceeded, FSANZ proactively gathers data on the national food supply to assess actual consumer exposure and risk.

This approach allows the agency to make evidence-based decisions about the necessity of new regulations and to work with industry to keep contaminant levels low, potentially averting the need for large-scale consumer recalls by addressing risks at a systemic level.

Section V: Scientific and Toxicological Profile of Key Contaminants

Understanding the nature of the contaminants found in recalled apple juice is essential for appreciating the public health risks involved.

The primary chemical and biological hazards identified in recent incidents—inorganic arsenic and patulin—have distinct origins, mechanisms of toxicity, and levels of concern, particularly for vulnerable populations such as children.

Inorganic Arsenic

Arsenic is a naturally occurring element found in the Earth’s crust and is widely distributed in the environment in soil, water, and air.²⁰

Its presence in the food supply can be attributed to both natural absorption by plants from the environment and human activities.

Historically, the use of arsenic-based pesticides, such as lead arsenate in apple orchards until the mid-20th century, contributed to soil contamination in some agricultural areas.³³

Although such pesticides are now banned for food crops in the U.S., arsenic is environmentally persistent and can remain in the soil for decades.³³

Arsenic exists in two primary forms: organic and inorganic.

While organic forms are generally considered less harmful, inorganic arsenic is highly toxic and is classified as a known human carcinogen by the U.S. Environmental Protection Agency (EPA) and the International Agency for Research on Cancer.¹⁵

Chronic exposure to inorganic arsenic, even at low levels, is associated with a range of severe health effects, including an increased risk of skin, bladder, and lung cancers, as well as skin lesions, cardiovascular disease, and diabetes.¹⁵

Children and infants are particularly vulnerable to the toxic effects of arsenic.

Due to their lower body weight, rapid metabolism, and higher relative consumption of foods like apple juice, their exposure dose can be significantly higher than that of adults.²

For developing children, arsenic exposure has been linked to adverse neurodevelopmental outcomes, including learning disabilities, behavioral problems, and lower IQ.²

Patulin

Patulin is a mycotoxin, a toxic secondary metabolite produced by several species of mold, most notably Penicillium expansum, which causes a common “blue mold” rot on apples.³

The mold thrives on apples that have been damaged, bruised, dropped, or improperly stored, allowing the fungus to invade the fruit’s tissue and produce the toxin.²⁹

A critical food safety concern with patulin is its stability.

The toxin is not destroyed by heat during the pasteurization process.¹²

Therefore, if juice is made from moldy or poor-quality apples, the patulin will be carried over into the final product, regardless of subsequent heat treatment.

The FDA notes that even one highly contaminated apple can be sufficient to raise the patulin level of an entire batch of juice above the established action level.²⁹

Unlike inorganic arsenic, the primary health risks associated with patulin are acute rather than chronic.

Ingestion of high levels of patulin can lead to immediate gastrointestinal distress, with symptoms including nausea, vomiting, abdominal pain, and ulcers.²²

While some studies have suggested it may be genotoxic (damaging to genetic material), its potential as a carcinogen in humans is not well-established.²³

Other Contaminants

Beyond arsenic and patulin, other contaminants have been the subject of recalls and regulatory concern in apple-based and other food products.

• Lead: Like arsenic, lead is a heavy metal and a potent neurotoxin. It was a contaminant of concern in the 2023 recall of cinnamon applesauce pouches ⁴⁰ and has been a focus of consumer advocacy groups examining fruit juices.⁴¹ Lead exposure is particularly dangerous for children, as it can cause irreversible damage to the developing brain and nervous system.
• Physical Hazards: As demonstrated by the 2023 recall in the United Kingdom, physical contaminants such as metal fragments pose an immediate safety risk.⁴ These hazards can cause injury to the mouth, throat, or digestive tract. They typically result from failures in manufacturing equipment or packaging materials rather than agricultural contamination.

Section VI: Comparative Analysis of Regulatory Frameworks and Enforcement

The effectiveness of a food safety system is heavily dependent on the regulatory framework established by national authorities.

A comparative analysis of the approaches taken by the United States, Canada, the European Union, and Australia/New Zealand regarding key contaminants in apple juice reveals significant differences in philosophy, from non-binding guidance to legally enforceable limits and proactive surveillance.

United States (FDA)

The U.S. Food and Drug Administration (FDA) primarily relies on a system of non-binding “action levels” for certain unavoidable environmental contaminants in food.

These levels represent a threshold above which the FDA may take enforcement action, but they are not legally enforceable maximum limits.²¹

• Inorganic Arsenic: In June 2023, the FDA finalized its guidance for an action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice.²¹ This level was first proposed in 2013, a decade prior, and its finalization followed years of advocacy from consumer groups.⁴³ The Refresco recall was triggered when its products tested at 13.2 ppb, exceeding this guidance level.¹⁵
• Patulin: The FDA has an established action level for patulin in apple juice of 50 ppb (50 µg/kg).²⁹ This level is consistent with the international standard set by the Codex Alimentarius Commission.⁴⁶

This approach provides flexibility but has been criticized for its lack of legal teeth and the slow pace at which guidance is finalized, potentially leaving consumers exposed to risks in the interim.⁴¹

Canada (CFIA) & European Union (EC)

In contrast to the U.S. model, both Canada and the European Union utilize legally binding Maximum Levels (MLs) for contaminants like patulin.

These MLs are enforceable by law, meaning any product exceeding the limit is considered adulterated and cannot be legally sold.

• Patulin: Both Health Canada and the European Commission have set a Maximum Level of 50 ppb for patulin in apple juice, aligning with the Codex standard.⁴⁷ This provides a clear and enforceable benchmark for industry and regulators.
• Stricter Limits for Vulnerable Groups: The European Union has taken an additional step to protect children by establishing a much stricter ML of 10 ppb for patulin in apple juice and solid apple products specifically marketed for infants and young children.⁴⁸ This risk-based approach recognizes the heightened vulnerability of this demographic.
• Arsenic: The EU also has established MLs for inorganic arsenic in various foods, including rice and baby foods, though a specific level for apple juice is part of a broader category of fruit juices.⁴⁸

Australia/New Zealand (FSANZ)

Food Standards Australia New Zealand (FSANZ) employs a different approach that combines overarching principles with proactive data gathering.

• General Provisions: The Australia New Zealand Food Standards Code does not set a specific ML for patulin or inorganic arsenic in apple juice.¹¹ Instead, it relies on general provisions requiring that all food sold must be safe and suitable for consumption and that contaminant levels must be kept
  As Low As Reasonably Achievable (ALARA).¹¹
• Reference to International Standards: While not codified as a domestic ML, FSANZ and the Australian beverage industry use the Codex Alimentarius level of 50 ppb for patulin as a key safety benchmark and trade standard.¹²
• Proactive Surveillance: As detailed in Section IV, FSANZ’s primary strategy involves conducting regular, comprehensive national surveys to monitor actual contaminant levels in the food supply.¹¹ This data is then used to perform dietary exposure assessments and determine if specific regulatory measures, such as setting an ML, are warranted. This evidence-based approach aims to manage risk systemically rather than reacting to individual market incidents.

Table 6.1: International Regulatory Limits for Contaminants in Apple Juice (ppb or µg/kg)

This table summarizes the different regulatory thresholds for inorganic arsenic and patulin in apple juice across the analyzed regions, highlighting the key differences in their approaches.

Contaminant	USA (FDA)	Canada (CFIA)	European Union (EC)	Australia/NZ (FSANZ)
Inorganic Arsenic	10 ppb (Action Level)¹	No specific ML for apple juice	10-50 ppb (ML for fruit juices)²	No specific ML; ALARA principle applies³
Patulin	50 ppb (Action Level)¹	50 ppb (Maximum Level)	50 ppb (Maximum Level)	No specific ML; ALARA principle applies³
Patulin (Infant Foods)	50 ppb (Action Level)¹	50 ppb (Maximum Level)	10 ppb (Maximum Level)	No specific ML; ALARA principle applies³

Notes:

¹ Action Level (FDA): A non-binding guidance level.

The FDA may take regulatory action if the level is exceeded, but it is not a legal limit.

² Maximum Level (ML): A legally enforceable limit.

Products exceeding this level are prohibited from sale.

The EU limit for arsenic in fruit juices ranges from 10 to 50 ppb depending on the specific product type.48

³ ALARA Principle (FSANZ): Contaminants must be kept “As Low As Reasonably Achievable.” FSANZ references the 50 ppb Codex level for patulin as a benchmark but does not have a specific ML in its code.

Section VII: Historical Context and the Role of Consumer Advocacy

The recent recalls of apple juice for heavy metal contamination are not isolated incidents but rather the latest chapter in a long-running public health debate.

For over a decade, consumer advocacy organizations, most notably Consumer Reports, have played a pivotal role in investigating contaminants in fruit juices, raising public awareness, and pressuring regulatory agencies to strengthen safety standards.

The Consumer Reports Investigations

In 2011, Consumer Reports published a landmark investigation that brought the issue of arsenic in apple and grape juice to national prominence.⁴¹

After testing 88 samples, the organization found that roughly 10% had total arsenic levels exceeding the federal drinking water standard of 10 ppb.

Furthermore, 25% of samples had lead levels exceeding the 5 ppb limit for bottled water.⁵²

This report, coming shortly after a segment on “The Dr. Oz Show” raised similar concerns, created a media firestorm and placed significant pressure on the FDA, which at the time did not have a specific guidance level for arsenic in juice.⁴¹

The investigation highlighted that much of the arsenic was the more toxic inorganic form and noted the industry’s increasing reliance on apple juice concentrate from international sources like China, where arsenic-based pesticides were still in use.⁴¹

Following this initial report, the FDA proposed its 10 ppb action level for inorganic arsenic in apple juice in 2013.²¹

However, this proposal remained in draft form for a decade.

In late 2018 and early 2019, Consumer Reports conducted a follow-up investigation, expanding its scope to include cadmium and mercury in addition to arsenic and lead.⁴⁴

Testing 45 popular fruit juices, including apple, grape, and fruit blends, the study found that nearly half (21 of 45) had “concerning levels” of at least one of the heavy metals.⁴⁴

The report specifically noted that grape juice and juice blends had the highest average heavy metal levels and that organic juices did not necessarily have lower levels than their conventional counterparts.⁵⁴

Based on these findings, Consumer Reports formally petitioned the FDA, urging the agency to:

1. Immediately finalize the long-proposed 10 ppb action level for inorganic arsenic in apple juice.
2. Establish a stricter, broader limit of 3 ppb for inorganic arsenic in all fruit juices.
3. Set new, more protective limits of 1 ppb for lead and cadmium in all fruit juices.⁴⁴

Regulatory Action Driven by Public Pressure

The timeline of events surrounding the regulation of arsenic in apple juice strongly suggests that regulatory action in the United States has been significantly influenced by external pressure from consumer advocates and the public.

The initial investigation by Consumer Reports in 2011 served as a catalyst, directly leading to the FDA’s 2013 proposal of a 10 ppb action level.²¹

However, the subsequent decade of regulatory inaction, during which the 10 ppb level remained a mere proposal, demonstrates a significant institutional inertia.

It was only after continued advocacy, including the 2018/2019 follow-up report from Consumer Reports and growing public concern over heavy metals in baby foods, that the FDA moved to finalize the guidance in June 2023.²¹

This pattern—public alarm followed by proposed regulation, then a long period of delay until further public pressure forces finalization—indicates that external advocacy has been a necessary, and perhaps primary, driver for advancing this specific public health standard.

Without the persistent investigation and public dissemination of findings by organizations like Consumer Reports, it is plausible that the non-binding 10 ppb guidance level would not have been finalized, leaving the public and the industry with even less clarity on safety benchmarks.

Section VIII: Analysis, Insights, and Recommendations for Stakeholders

The recent series of apple juice recalls across multiple English-speaking countries provides a clear and compelling picture of the multifaceted challenges facing the modern food system.

The analysis of these events reveals critical vulnerabilities in supply chain structures, highlights disparities in international regulatory approaches, and underscores the ongoing need for vigilance from all stakeholders—consumers, industry, and government agencies.

Synthesis of Findings

Three core vulnerabilities have emerged from this analysis.

First, the opacity of the co-packer model represents a significant systemic risk.

The consolidation of manufacturing into large, third-party facilities like those operated by Refresco means that a single point of failure—whether from contaminated raw materials or a faulty packaging line—can trigger a massive, multi-brand recall that crosses international borders.

This structure obscures accountability and makes it difficult for consumers to make informed choices based on brand reputation alone.

Second, the slow pace and non-binding nature of U.S. regulatory standard-setting for certain contaminants stand in contrast to the more stringent and legally enforceable frameworks in other developed nations.

The decade-long delay in finalizing a non-binding “action level” for arsenic in apple juice exemplifies a reactive posture that relies heavily on industry self-policing and can be slow to adapt to emerging public health science and consumer concerns.

Third, the recalls demonstrate the dual nature of food safety risks, which arise from both agricultural sources (e.g., arsenic in soil, patulin on fruit) and industrial processing (e.g., metal fragments from equipment).

A comprehensive food safety program must therefore address potential hazards from the farm all the way to the final packaged product.

Recommendations for Consumers

To navigate this complex landscape, consumers are advised to take the following steps:

• Stay Informed: Regularly check official recall databases, such as those maintained by the FDA in the U.S., the CFIA in Canada, the FSA in the U.K., and FSANZ in Australia. Subscribing to email alerts from these agencies can provide timely notifications.⁵⁵
• Diversify Diets: Public health experts and pediatricians consistently advise limiting juice consumption for children in favor of whole fruit and water.³⁵ This not only reduces sugar intake but also mitigates the risk of overexposure to any single contaminant that may be present in a specific food product.
• Heed Recall Instructions: If a product in possession matches all identifiers in a recall notice (brand, size, UPC, and date codes), consumers should immediately cease consumption and follow the company’s instructions, which typically involve either discarding the product or returning it to the place of purchase for a full refund.²

Recommendations for the Food Industry

To rebuild consumer trust and prevent future incidents, the food and beverage industry should prioritize the following actions:

• Enhance Supply Chain Transparency and Testing: Manufacturers, particularly large co-packers, must implement more rigorous and frequent testing of raw materials, especially globally sourced ingredients like apple juice concentrate. Certificates of analysis from suppliers should be independently verified.
• Strengthen HACCP and Quality Control Systems: Companies must maintain robust Hazard Analysis and Critical Control Point (HACCP) plans that comprehensively address both agricultural chemical hazards (like arsenic and patulin) and physical processing hazards (like foreign materials).²⁹ Regular audits and stress-testing of these systems are essential.
• Improve Traceability: Investment in modern traceability technology is crucial to enable rapid identification and isolation of contaminated products, minimizing the scope of recalls and protecting public health more effectively.

Recommendations for Regulators

To better protect public health, regulatory agencies should consider the following policy enhancements:

• Move Toward Enforceable Limits: The FDA should transition from non-binding “action levels” to legally enforceable “maximum levels” for high-risk contaminants like inorganic arsenic and lead in fruit juices. This would harmonize U.S. standards with those of many international partners and provide a clearer, more effective enforcement tool.
• Adopt Proactive Surveillance Models: Regulatory bodies in the U.S. and U.K. could benefit from adopting elements of the proactive, survey-based risk assessment model used by FSANZ. Systematically testing the food supply to understand baseline contaminant levels can identify emerging risks and inform targeted, preventative industry guidance before a crisis occurs.
• Accelerate Standard-Setting: Regulatory processes for establishing and finalizing food safety standards must be streamlined. The decade-long period between the proposal and finalization of the arsenic action level is unacceptable for a known public health risk, particularly one that disproportionately affects children. Agencies must be empowered and resourced to act decisively based on the best available science.

Works cited

1. Apple juice recall grows due to arsenic concerns: Full list | wusa9.com, accessed on August 13, 2025, https://www.wusa9.com/article/news/nation-world/apple-juice-recall-expanded-full-list/507-9b93d234-d469-4ff2-b6bb-71315eed8f87
2. Apple Juice Sold at Walmart, Aldi, and BJ’s Recalled Over Arsenic Concerns – Parents, accessed on August 13, 2025, https://www.parents.com/apple-juice-recall-expands-8711545
3. FDA Recalls More Than 170,000 Bottles of Apple Juice – Food & Wine, accessed on August 13, 2025, https://www.foodandwine.com/martinellis-apple-juice-recall-patulin-mycotoxin-11722047
4. Heading The UK Food Standards Agency (FSA) – A notice regarding a recall of several Calypso and Asda brand juice drinks in the, accessed on August 13, 2025, https://www.cfs.gov.hk/english/rc/subject/files/20240102_1.pdf
5. 2023.12.20 Recall: Asda / Calypso – Various Juices – London Borough of Richmond upon Thames, accessed on August 13, 2025, https://www.richmond.gov.uk/tsleaflets?article=334439
6. Refresco Beverages UK Limited recalls several juice drinks because of potential metal contamination in the straws | Food Standards Agency, accessed on August 13, 2025, https://www.food.gov.uk/news-alerts/alert/fsa-prin-47-2023
7. Update 1: Refresco Beverages UK Limited recalls several juice …, accessed on August 13, 2025, https://www.food.gov.uk/news-alerts/alert/fsa-prin-47-2023-update-1
8. Eden brand Organic Apple Juice recalled due to patulin – Canada.ca, accessed on August 13, 2025, https://recalls-rappels.canada.ca/en/alert-recall/eden-brand-organic-apple-juice-recalled-due-patulin
9. Heading The Canadian Food Inspection Agency (CFIA) – Recall of Heinz brand Apple Juice from Concentrate in Canada by Kraft Hei, accessed on August 13, 2025, https://www.cfs.gov.hk/english/rc/subject/files/20170408_1.pdf
10. The FDA is posting Canadian Food Inspection Agency’s recall notice to alert U.S. consumers who may have purchased these products in Canada not to eat or serve them. The products under recall were manufactured specifically for the Canadian market., accessed on August 13, 2025, https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fda-posting-canadian-food-inspection-agencys-recall-notice-alert-us-consumers-who-may-have-purchased
11. Patulin – Food Standards Australia New Zealand, accessed on August 13, 2025, https://www.foodstandards.gov.au/publications/patulin
12. Survey of patulin in apple juice and other apple products – Food Standards Australia New Zealand, accessed on August 13, 2025, https://www.foodstandards.gov.au/sites/default/files/2023-12/Survey-of-patulin-in-apple-juice-and-other-apple-products_Report.pdf
13. Survey of Metals in Apple Juice and Other Apple Products, accessed on August 13, 2025, https://www.foodstandards.gov.au/publications/survey-metals-apple-juice-and-other-apple-products
14. Walmart Recalls Nearly 10,000 Cases of Apple Juice Due to Elevated Levels of Arsenic, accessed on August 13, 2025, https://ca.news.yahoo.com/walmart-recalls-nearly-10-000-135745613.html
15. Apple Juice Recall Update as FDA Issues Warning Over Arsenic Levels – Newsweek, accessed on August 13, 2025, https://www.newsweek.com/apple-juice-recall-update-fda-sets-risk-level-over-arsenic-levels-1944037
16. Over 133,000 Cases of Apple Juice Recalled Nationwide Due to Potentially Harmful Arsenic Levels – Allrecipes, accessed on August 13, 2025, https://www.allrecipes.com/nationwide-apple-juice-recall-september-2024-8709186
17. More apple juice is being recalled over high levels of arsenic – YouTube, accessed on August 13, 2025, https://www.youtube.com/watch?v=Db2_wwwmG5M&pp=0gcJCf0Ao7VqN5tD
18. Apple juice recall: 133,000 cases of juice sold in several states now included – YouTube, accessed on August 13, 2025, https://www.youtube.com/watch?v=7JALuVOoHoE
19. Great Value Apple Juice recalled over high levels of arsenic | Food Safety News, accessed on August 13, 2025, https://www.foodsafetynews.com/2024/08/great-value-apple-juice-recalled-over-high-levels-of-arsenic/
20. Apple juice recall expanded over arsenic concerns | FOX 13 Tampa Bay, accessed on August 13, 2025, https://www.fox13news.com/news/apple-juice-recall-expanded-arsenic-refresco-fda
21. FDA Issues Final Guidance to Industry on Action Level for Inorganic Arsenic in Apple Juice, accessed on August 13, 2025, https://www.fda.gov/food/hfp-constituent-updates/fda-issues-final-guidance-industry-action-level-inorganic-arsenic-apple-juice
22. 170K bottles of apple juice recalled over potential toxic mold contamination – Product Safety Recall | News | Office of Children and Family Services, accessed on August 13, 2025, https://ocfs.ny.gov/main/news/recalls/article.php?idx=206
23. Recall alert: 173K bottles of Martinelli’s apple juice recalled – WFTV, accessed on August 13, 2025, https://www.wftv.com/news/trending/recall-alert-173k-bottles-martinellis-apple-juice-recalled/OPFVEYFHIZAOLNNBB3YWWONDTA/
24. Apple juice recalled in 28 states due to toxic substance, FDA says – Fox News, accessed on August 13, 2025, https://www.foxnews.com/food-drink/apple-juice-recalled-28-states-due-toxic-substance-fda-says
25. Martinelli’s recalls Apple Juice due to Patulin contamination – Ingredient Brothers, accessed on August 13, 2025, https://source86.com/martinellis-recalls-apple-juice-due-to-patulin-contamination/
26. Martinelli’s Apple Juice Recalled Because of Mold Contamination – Taste of Home, accessed on August 13, 2025, https://www.tasteofhome.com/article/apple-juice-recall-2025/
27. Patulin in Apples and Apple-Based Food Products: The Burdens and the Mitigation Strategies – PMC – PubMed Central, accessed on August 13, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC6267208/
28. Patulin: the whats, whys and hows – Factssa, accessed on August 13, 2025, https://www.factssa.com/news/patulin-the-whats-whys-and-hows/
29. Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition March 2004 – FDA, accessed on August 13, 2025, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-hazard-analysis-critical-control-point-hazards-and-controls-guidance-first
30. Martinelli’s recalls 170000 apple juice bottles over risk of toxic substance from fungi, accessed on August 13, 2025, https://www.cbsnews.com/news/martinellis-recalls-170000-apple-juice-martinelli-bottles-toxin-patulin/
31. Refresco Beverages UK Limited recalls several juice drinks because of potential metal contamination in the straws – View PDF, accessed on August 13, 2025, https://www.food.gov.uk/print/pdf/node/21841
32. Reducing the risk of recalls – Food & Drink Business, accessed on August 13, 2025, https://www.foodanddrinkbusiness.com.au/news/reducing-the-risk-of-recalls
33. Apple Juice and Arsenic Backgrounder – USApple, accessed on August 13, 2025, https://usapple.org/news-resources/apple-juice-and-arsenic-backgrounder
34. Walmart is recalling apple juice due to high arsenic levels. Why is arsenic in it in the first place? : r/NoStupidQuestions – Reddit, accessed on August 13, 2025, https://www.reddit.com/r/NoStupidQuestions/comments/1f1p6o0/walmart_is_recalling_apple_juice_due_to_high/
35. Arsenic in apple juice: Should you be worried about Walmart’s recent recall?, accessed on August 13, 2025, https://news.northeastern.edu/2024/08/28/arsenic-in-apple-juice/
36. FDA Updates Recall of Arsenic-Tainted Apple Juice Sold at Walmart – WebMD, accessed on August 13, 2025, https://www.webmd.com/food-recipes/food-poisoning/news/20240826/fda-updates-recall-arsenic-tainted-apple-juice-sold-walmart
37. Arsenic and Lead in Our Juice (And You Thought Poisoned Apples Were Only in Fairy-tales!), accessed on August 13, 2025, https://www.center4research.org/arsenic-lead-juice-thought-poisoned-apples-fairy-tales/
38. Code of Practice for the Prevention and Reduction of Patulin Contamination in Apple Juice and Apple Juice Ingredients in Other Beverages, accessed on August 13, 2025, https://www.fao.org/input/download/standards/405/CXP_050e.pdf
39. Patulin Fact Sheet and Technical Guidance Document – Australian Beverages Council, accessed on August 13, 2025, https://www.australianbeverages.org/wp-content/uploads/2021/09/Patulin-Fact-Sheet-Final.pdf
40. Investigation of Elevated Lead & Chromium Levels: Cinnamon Applesauce Pouches (November 2023) | FDA, accessed on August 13, 2025, https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-chromium-levels-cinnamon-applesauce-pouches-november-2023
41. Did the FDA Ignore Earlier Reports of Elevated Arsenic Levels in Juices?, accessed on August 13, 2025, https://jjie.org/2011/12/16/did-fda-ignore-earlier-reports-of-elevated-arsenic-levels-juices/
42. Guidance for Industry: Action Level for Inorganic Arsenic in Apple Juice June 2023 – FDA, accessed on August 13, 2025, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-action-level-inorganic-arsenic-apple-juice
43. FDA sets 10 ppb limit for arsenic in apple juice | C&EN Global Enterprise – ACS Publications, accessed on August 13, 2025, https://pubs.acs.org/doi/10.1021/cen-10119-polcon2
44. Consumer Reports letter to FDA on reducing heavy elements like …, accessed on August 13, 2025, https://advocacy.consumerreports.org/research/consumer-reports-letter-to-fda-on-reducing-heavy-elements-like-arsenic-lead-and-cadmium-in-fruit-juices/
45. Over 7,000 apple juice boxes recalled in 28 US states due to possible contamination, accessed on August 13, 2025, https://www.freshfruitportal.com/news/2025/04/28/over-7000-apple-juice-boxes-recalled-in-28-us-states-due-to-possible-contamination/
46. codex alimentarius commission – Food and Agriculture Organization of the United Nations, accessed on August 13, 2025, https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FShared%2BDocuments%252FArchive%252FMeetings%252FCCFAC%252Fccfac34%252Ffa02_19e.pdf
47. Proposal to transfer Health Canada’s maximum level for patulin in apple juice and unfermented apple cider to the List of Contaminants and Other Adulterating Substances in Foods – Canada.ca, accessed on August 13, 2025, https://www.canada.ca/en/health-canada/programs/consultation-proposal-update-maximum-levels-patuling-apple-cider.html
48. Food Contaminant Testing by EU Regulations – Measurlabs, accessed on August 13, 2025, https://measurlabs.com/blog/eu-regulations-on-food-contaminants/
49. Patulin in apple juice – NIAB, accessed on August 13, 2025, https://www.niab.com/patulin-apple-juice
50. Arsenic – Food Standards Australia New Zealand, accessed on August 13, 2025, https://www.foodstandards.gov.au/consumer/chemicals/arsenic
51. Patulin in Apple Juice products – Australian Beverages Council, accessed on August 13, 2025, https://www.australianbeverages.org/patulin-in-apple-juice-products-2/
52. Arsenic in Apple Juice: A New Report Suggests Widespread Exposure | TIME, accessed on August 13, 2025, https://time.com/archive/7139844/arsenic-in-apple-juice-a-new-report-suggests-widespread-exposure/
53. Consumer Reports: Arsenic and Lead Are in Your Fruit Juice, What You Need to Know – Children’s Mercy Kansas City, accessed on August 13, 2025, https://news.childrensmercy.org/consumer-reports-arsenic-and-lead-are-in-your-fruit-juice-what-you-need-to-know/
54. Consumer Reports juice study finds ‘concerning’ levels of heavy metals | FOX 13 Tampa Bay, accessed on August 13, 2025, https://www.fox13news.com/news/consumer-reports-juice-study-finds-concerning-levels-of-heavy-metals
55. Food recalls and alerts – Canada.ca, accessed on August 13, 2025, https://www.canada.ca/en/services/health/food-recalls-alerts.html
56. Food safety investigations and recalls – inspection.canada.ca, accessed on August 13, 2025, https://inspection.canada.ca/en/food-safety-industry/investigations-and-recalls
57. Heavy metals like arsenic and lead found in 45 packaged fruit juices, report finds – YouTube, accessed on August 13, 2025, https://www.youtube.com/watch?v=N3zLaDDEQ0E