Investigation of Elevated Lead Levels: Cinnamon Applesauce Pouches (November 2023)

Do not eat, sell, or serve multiple brands of recalled apple cinnamon fruit pouches. FDA’s investigation is ongoing.

Investigation of Elevated Lead Levels: Applesauce Pouches (November 2023)

Product

Recalled cinnamon apple puree and applesauce products. Information on lot codes and UPCs can be found in the firm's recall announcement.

Recalled WanaBana apple cinnamon fruit puree pouches
Recalled Schnucks-brand cinnamon-flavored applesauce pouches and variety pack
Recalled Weis-brand cinnamon applesauce pouches

Symptoms of Lead Toxicity

Lead is toxic to humans and can affect people of any age or health status. Protecting children from exposure to lead is particularly important because they are more susceptible to lead toxicity. Most children have no obvious immediate symptoms. Parents and caretakers should consult a healthcare provider if you suspect a child may have been exposed to lead. Short term exposure to lead could result in the following symptoms: headache; abdominal pain/colic; vomiting; anemia. Longer term exposure could result in the following additional symptoms: irritability; lethargy; fatigue; muscle aches or muscle prickling/burning; constipation; difficulty concentrating/muscular weakness; tremor; weight loss.

Stores Affected

WanaBana apple cinnamon fruit puree pouches are sold nationally and are available through multiple retailers including Amazon, Dollar Tree, and other online outlets.
- FDA is aware that recalled WanaBana Apple Cinnamon Puree is still on the shelves at several Dollar Tree stores in multiples states. This product should not be available and consumers should not purchase this product.
Schnucks-brand cinnamon-flavored applesauce pouches and variety pack are sold at Schnucks and Eatwell Markets grocery stores.
Weis-brand cinnamon applesauce pouches are sold at Weis grocery stores.

Status

Ongoing; updates to this advisory will be provided as they become available.

Recommendation

Consumers should not eat, sell, or serve recalled WanaBana, Schnucks, or Weis-brand apple cinnamon pouches and should discard them.
These products have a long shelf life. Consumers should check their homes and discard these products.
To properly discard the product, consumers and retailers should carefully open the pouch and empty the content into a trash can before discarding the packaging to prevent others from salvaging recalled product from the trash. Clean up any spills after discarding the product then wash your hands.
Most children have no obvious immediate symptoms of lead exposure. If there’s suspicion that a child may have been exposed to lead, parents should talk to their child’s healthcare provider about getting a blood test.
Contact your healthcare provider if you think you may have symptoms of lead toxicity after eating recalled fruit pouches.
If you or your child have symptoms or exposure to this product, you can also file a complaint or adverse event report (illness or serious allergic reaction).

Current Update

November 30, 2023

On November 30, 2023, Austrofood, along with Wanabana USA, the distributor of WanaBana products in the United States, released a statement that reports that Wanabana has conducted a root cause investigation. Based on this investigation, the firm’s leading hypothesis to date is that the cinnamon is the source of the elevated lead levels in the recalled products. The statement released today by Wanabana USA and Austrofood states that the cinnamon used to manufacture the recalled products was supplied by Negocios Asociados Mayoristas S.A., operating as Negasmart, a third-party distribution company located in Ecuador.

The FDA is continuing to work with Ecuadorian authorities to investigate the source of the contamination and to determine if the cinnamon in the recalled products was used in other products or distributed as a raw ingredient to other countries. FDA has confirmed that Negasmart does not import cinnamon directly into the U.S.

As of November 30, 2023, there have been 57 reports of adverse events potentially linked to recalled product submitted to FDA. To date, confirmed complainants are less than 1 to 5 years of age.

The FDA relies on self-reported information submitted by healthcare providers, consumers, and some state partners who submitted an adverse event report to FDA as an initial step in determining if a product is a potential shared source of exposure amongst complainants. Unlike outbreaks of foodborne illnesses that are genetically linked to pathogens, there is no method to link lead exposure to a specific source, which can make establishing a causal relationship complicated.

While our total reports included in this advisory represent complaints that have been reported to FDA, we recognize there are other avenues for reporting of elevated lead levels. For example, through case reporting from the state health departments to CDC which is routinely done for cases of childhood lead exposure. Because these different avenues for reporting represent two different mechanisms of collecting data, we are currently not including them in our advisory. However, we are working with our state partners and CDC to gather and evaluate as much data as possible, while recognizing there are different mechanisms being leveraged.

FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. At this time, FDA has no indication that this issue extends beyond these recalled products, but to further protect public health, FDA is screening incoming shipments of cinnamon from multiple countries for lead contamination. As of November 30, 2023, there have been no screening results that have tested positive for higher levels of lead. Separately, Austrofood CIA LDA’s apple cinnamon fruit puree pouch products exported to the U.S. were added to Import Alert 99-42, detention without physical examination of foods due to heavy metal (toxic element) contamination.

FDA will update the advisory as information becomes available.

Adverse Event Overview

Total FDA Adverse Events: 57*
Report Date Ranges: October 17, 2023 – November 28, 2023
States with Adverse Illness Events: AL (1), AR (1), CA (1), CT (1), FL (1), GA (2) IA (1), IL (2), KY (3), LA (4), MA (3), MD (4), MI (3), MO (1), NC (5), NE (1), NH (1), NM (1), NY (8), OH (2), PA (1), SC (2), TN (1), TX (3) VA (1), WA (3)
Product Distribution: Nationwide

*Estimate based on Consumer Complaint and CFSAN Adverse Event Reporting System (CAERS) reports received by the FDA.

Useful Links

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Recalled Product

In response to this investigation, Wanabana has voluntarily recalled all WanaBana Apple Cinnamon Fruit Puree Pouches regardless of expiration date and lot code. Two additional brands of products are also subject to recall: certain Schnucks cinnamon-flavored applesauce pouches and variety pack and certain Weis cinnamon applesauce pouches.

International Distribution for Recalled Products

The recall impacts markets outside of the United States. Customer information provided by the firm shows that product was also distributed to Cuba and the United Arab Emirates.

Previous Updates

November 22, 2023

FDA, along with CDC and state and local partners, is investigating reports of elevated blood lead levels in individuals with reported exposure to Apple Cinnamon Fruit Puree pouches manufactured in Ecuador and sold under WanaBana, Weis, and Schnucks brands.

As of November 22, 2023, there have been 52 reports of adverse events potentially linked to recalled product submitted to FDA. To date, confirmed complainants are less than 1 to 4 years of age. FDA is continuing to evaluate incoming adverse event reports.

FDA is aware that recalled WanaBana Apple Cinnamon Puree is still on the shelves at several Dollar Tree stores in multiple states. FDA is working with the firm to ensure an effective recall. This product should not be available for sale and consumers should not purchase or consume this product as it is potentially contaminated with lead, which can be harmful to health, particularly for children.

To properly discard the product, consumers and retailers should carefully open the pouch and empty the content into a trash can before discarding the packaging to prevent others from salvaging recalled product from the trash. Clean up any spills after discarding the product then wash your hands.

FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. At this time, the FDA is not aware of any other reports of illnesses or elevated blood lead level adverse events reported for other cinnamon-containing products or cinnamon.

FDA will update the advisory as information becomes available.

November 16, 2023

As of November 16, 2023, there have been 34 reports of illness potentially linked to recalled product submitted to FDA. FDA is continuing to evaluate incoming adverse reports of illnesses.

FDA and other state partners collected and analyzed additional product samples of fruit puree and applesauce pouches. FDA detected elevated levels of lead in one finished product sample of WanaBana Apple Cinnamon Puree collected from Dollar Tree. The level detected in the FDA sample of WanaBana apple cinnamon puree is 2.18 parts per million (ppm), which, for context, is more than 200 times greater than the action level the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children.

To date, sample analysis of WanaBana, Weis, and Schnucks fruit puree pouches that do not contain cinnamon and are not part of the recall, have not shown elevated levels of lead.

FDA’s leading hypothesis is that cinnamon used in these recalled pouches is the likely source of contamination for these products; however, the FDA has not yet been able to collect and test samples of the cinnamon used in the recalled products. The FDA is continuing to work with Ecuadorian authorities to investigate the source of the cinnamon. At this time, FDA has no indication that this issue extends beyond these recalled products, but to further protect public health, FDA is screening incoming shipments of cinnamon from multiple countries for lead contamination.

In addition to determining the source of cinnamon, FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. At this time, the FDA is not aware of any other reports of illnesses or elevated blood lead level adverse events reported for other cinnamon-containing products or cinnamon.

The FDA also reminds industry that it is the legal responsibility of companies distributing food products that are sold in the U.S., to comply with applicable requirements in the Federal Food, Drug, and Cosmetic Act and FDA's regulations.

By law, food manufacturers have a responsibility to significantly minimize or prevent chemical hazards when needed. This includes putting in place any needed preventive controls to reduce or eliminate the presence of lead in their products. Most food manufacturers and processors are covered by the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule. The preventive control provisions require industry to implement controls to significantly minimize or prevent any identified chemical hazards, such as lead, requiring a control. In addition, some manufacturers may conduct verification activities like testing the final product.

For more information please see FDA’s Draft Guidance for Industry on Hazard Analysis and Risk-Based Preventive Controls for Human Food.

FDA will update this advisory as information becomes available.

November 13, 2023

As reported in a safety alert issued by FDA on October 28, 2023, the FDA, along with the North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Agriculture & Consumer Services (NCDA&CS) are investigating reports of four children with elevated blood lead levels, indicating potential acute lead toxicity. The NCDHHS investigation identified WanaBana Apple Cinnamon Fruit Puree pouches as a potential shared source of exposure. As part of their investigation, NCDHHS analyzed multiple lots of WanaBana Apple Cinnamon Fruit Puree, detecting extremely high concentrations of lead. The FDA has reviewed and supports NCDHHS’s analytical findings and determined that levels of lead found in the analyzed pouches could result in acute lead toxicity.

As of November 13, 2023, there have been 22 reports of illness potentially linked to recalled product submitted to FDA. As part of this investigation, FDA and state partners are collecting and analyzing additional product samples of fruit puree and applesauce pouches. At this time, sample analyses have not shown elevated levels of lead in any non-recalled products.

On October 31, 2023, Wanabana LLC initiated a voluntary recall of all WanaBana Apple Cinnamon Fruit Puree Pouches. On November 9, 2023, Wanabana LLC expanded their recall announcement to include information on recalled Schnucks and Weis cinnamon applesauce pouches.

The recall impacts markets outside of the United States. Customer information provided by the firm shows that product was also distributed to Cuba and the United Arab Emirates.

Since the first alert was issued this investigation has been transferred to FDA’s Coordinated Outbreak Response & Evaluation (CORE) Network for additional follow up, in collaboration with the Centers for Disease Control and Prevention (CDC) and state and local partners. Two additional brands of products are also subject to recall: certain Schnucks cinnamon-flavored applesauce pouches and variety pack and certain Weis cinnamon applesauce pouches.

FDA is continuing to evaluate incoming reports of illnesses. FDA’s investigation is ongoing to determine the source of lead contamination and whether additional products are linked to illnesses. FDA will update this advisory as information becomes available.

November 3, 2023

The FDA has reviewed and supports NCDHHS’s analytical findings and found that analytical results at this level could result in acute toxicity. The FDA has shared the results with the firm and on October 31, 2023, Wanabana LLC initiated a voluntary recall of all WanaBana Apple Cinnamon Fruit Puree Pouches.

FDA has received additional reports of illnesses and is working to evaluate those complaints. FDA’s investigation is ongoing to determine the source of lead contamination and whether additional products are linked to illnesses. FDA will update this advisory as information becomes available.

October 28, 2023

The FDA was recently made aware of a developing investigation by the North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Agriculture & Consumer Services (NCDA&CS) regarding four children with elevated blood lead levels, indicating potential acute lead toxicity. The NCDHHS investigation identified WanaBana apple cinnamon fruit puree pouches as a potential shared source of exposure. As part of their investigation, NCDHHS analyzed multiple lots of WanaBana apple cinnamon fruit puree, detecting extremely high concentrations of lead. The FDA has reviewed and supports NCDHHS’s analytical findings and found that analytical results at this level could result in acute toxicity. The FDA has shared the results with the firm whose representatives are cooperating with the FDA and have agreed to voluntarily recall all WanaBana apple cinnamon fruit puree pouches regardless of expiration.

The FDA is issuing this public health alert advising parents and caregivers not to purchase or feed WanaBana apple cinnamon fruit puree pouches to toddlers and young children because they may contain elevated levels of lead. The FDA is continuing to work with state officials and the firm, collecting additional information, and taking steps to remove all contaminated product from the market.

Who to Contact

Consumers who have symptoms should contact their health care provider to report their symptoms and receive care.

To report a complaint or adverse event (illness or serious allergic reaction), you can

Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
Complete an electronic Voluntary MedWatch form online.
Complete a paper Voluntary MedWatch form that can be mailed to FDA.

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