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Investigation of Elevated Lead Levels in Applesauce Pouches

4 months ago

United States

Update December 5, 2023

The FDA has initiated an onsite inspection at the Austrofoods facility in Ecuador due to elevated lead levels in cinnamon apple pouches. Negasmart, the cinnamon supplier to Austrofoods, is under Ecuadorian sanctions for high lead levels. As of December 5, 2023, there are 64 adverse events reported from several states: AL (1), AR (1), CA (1), CT (1), FL (1), GA (2), IA (1), IL (3), KY (3), LA (4), MA (3), MD (6), MI (3), MO (1), NC (5), NE (2), NH (1), NM (1), NY (8), OH (3), PA (1), SC (2), TN (1), TX(3), VA(2), WA (3), WI (1), mainly affecting children under 6. Report Date Ranges: October 17, 2023 – December 1, 2023.

The CDC is collaborating with state health departments and as of December 1, 2023, has received reports of 18 confirmed cases, 30 probable cases, and 4 suspected cases from 13 different states: CO, FL, ID, IL, KS, KY, LA, MN, NE, OH, OR, TX, WV. The FDA and CDC use different data sources, and their reported numbers may not align. The investigations are ongoing

Source: FDA and CDC

Update November 30, 2023

On November 30, 2023, Austrofood and Wanabana USA issued a joint statement revealing the firm’s leading hypothesis that the cinnamon, supplied by Negasmart in Ecuador, is the source of contamination. The FDA, collaborating with Ecuadorian authorities, is probing the cinnamon's role and its potential use in other products. As of November 30, 2023, there are 57 adverse events reported from several states: 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), mainly affecting children under 5. Report Date Ranges: October 17, 2023 – November 28, 2023.

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.

Source: FDA

Update November 22, 2023

As of November 22, 2023, there have been 52 reports of adverse events potentially linked to recalled product submitted to FDA from several states: AL (1), AR (1), CA (1), CT (1), FL (1), GA (2) IA (1), IL (2), KY (2), LA (4), MA (2), MD (3), MI (3), MO (1), NC (5), NE (1), NH (1). NM (1), NY (7), OH (2), SC (2), TN (1), TX (3) VA (1), WA (3). To date, confirmed complainants are less than 1 to 4 years of age. FDA is continuing to evaluate incoming adverse event reports.

The affected products linked to this outbreak are Apple Cinnamon Fruit Puree pouches manufactured in Ecuador and sold under WanaBana, Weis, and Schnucks brands.

Source: FDA

Update November 16, 2023

As of November 16, 2023, there have been 34 reports of illness potentially linked to recalled products submitted to FDA from several states: AL (1), AR (1), CA (1), CT (1), FL (1), IL (1), LA (3), MD (2), MI (1), MO (1), NC (5), NE (1), NH (1), NM (1), NY (4), OH (1), PA (1), SC (2), TN (1), TX (1), VA (1), WA (1), Unknown (1). Report Date Ranges: October 17, 2023 – November 15, 2023. FDA is continuing to evaluate incoming adverse reports of illnesses.

Samples of WanaBana, Weis, and Schnucks fruit puree pouches without cinnamon and not part of the recall have shown no elevated lead levels. The FDA suspects that the recalled pouches were contaminated with lead from cinnamon, but hasn't tested the cinnamon yet. The FDA is working with Ecuadorian authorities to investigate the cinnamon source and is screening incoming cinnamon shipments from various countries for lead. The investigation is ongoing to identify the contamination point and any additional products linked to illnesses. Currently, there are no reports of illnesses or elevated lead levels from other cinnamon-containing products. The investigation is ongoing

Source: FDA

November 13, 2023

The FDA and other health agencies are currently investigating multiple brands of apple cinnamon fruit pouches due to Elevated Lead Levels. To date, 7 sick children have been reported linked to the consumption of these products from several states ( Arkansas (1), Louisiana (1), Maryland (1), Missouri (1) North Carolina (2), Unknown (1)). Report Date Ranges: October 17, 2023 – November 1, 2023. These products were distributed Nationwide in the US.

In an ongoing investigation that began in late October, the FDA in collaboration with North Carolina Department of Health and Human Services (NCDHHS) and other related agencies, have identified an alarming connection between the consumption of WanaBana Apple Cinnamon Fruit Puree and high blood lead levels. This probe was significantly initiated after 4 children showed elevated blood lead levels indicative of serious acute lead toxicity. Following this, subsequent lab testing has discovered high concentrations of the toxic lead in the tested WanaBana apple cinnamon puree pouches.

Further investigation into the outbreak has been handed over to FDA’s Coordinated Outbreak Response & Evaluation (CORE) Network to collaborate with state officials and the Centers for Disease Control and Prevention (CDC). 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.

The affected products are:
- WanaBana apple cinnamon fruit puree pouches. They were sold nationally and are available through multiple retailers including Amazon, Dollar Tree, and other online outlets.
- Schnuck brand cinnamon-flavored applesauce pouches and variety pack. They were sold at Schnucks and Eatwell Markets grocery stores.
- Weis brand cinnamon applesauce pouches (i.e., specific lots of UPC 041497216123). They were sold at Weis grocery stores.

Do not eat, sell, or serve these products. WanaBana LLC has voluntarily initiated a recall of all their apple puree products, regardless of the expiration date and lot codes. Furthermore, products like Schnucks and Weis brand cinnamon applesauce pouches have also been recalled. The FDA continues the investigation to identify the source of the lead contamination and whether further products are linked to this outbreak. Updates will be provided as they become available.

Primary symptoms of short-term exposure to lead toxicity include headaches, abdominal pain, and anemia among others; while longer-term exposure can escalate to fatigue, difficulty concentrating, tremor, and weight loss. Parents and caregivers are advised to be aware of these symptoms in children, who are particularly susceptible to lead toxicity.

If you or your child are experiencing symptoms after eating this product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.

Source: fda.gov

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Company name: BrightFarms, Inc.
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Product recalled: Bright Farms Southwest Chipotle Crunch Kit salad kit
Reason of the recall: Potential Listeria monocytogenes contamination
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Source: fda.gov
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