The following content is from the U.S Food and Drug Administration on October 28, 2023 and was not written by HVHD.
Audience
- Parents and caregivers of toddlers and young children who have recently purchased WanaBana apple cinnamon fruit puree pouches.
Product
- WanaBana apple cinnamon fruit puree pouches, all lot codes and expiration dates.
- WanaBana apple cinnamon fruit puree pouches are sold nationally and are available through multiple retailers including Sam’s Club, Amazon and Dollar Tree.
- WanaBana has agreed to voluntarily recall all WanaBana apple cinnamon fruit puree pouches regardless of expiration.
Purpose
The FDA is advising parents and caregivers not to buy or feed WanaBana apple cinnamon fruit puree pouches to children because the product may contain elevated levels of lead. Parents and caregivers of toddlers and young children who may have consumed WanaBana apple cinnamon fruit puree pouches should contact their child’s healthcare provider about getting a blood test.
Signs and 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 important to lifelong good health. Lead exposure in children is often difficult to see. Most children have no obvious immediate symptoms. 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. Although lead can only be diagnosed through clinical testing, signs and symptoms of lead toxicity vary based on exposure.
Short term exposure to lead could result in the following symptoms:
- Headache
- Abdominal pain/Colic
- Vomiting
- Anemia
Longer term exposure could result in additional symptoms:
- Irritability
- Lethargy
- Fatigue
- Muscle aches or muscle prickling/burning
- Occasional abdominal discomfort
- Constipation
- Difficulty concentrating/Muscular exhaustibility
- Headache
- Tremor
- Weight loss
Summary of Problem and Scope
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.
FDA Actions
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.
Recommendations for Consumers
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.
Visit www.fda.gov/fcic for additional consumer and industry assistance.
