FDA Warns Dollar Tree After Company Did Not Remove Product That Sickened Children

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FDA warns Dollar Tree with an official “Warning Letter” for failing to remove lead-tainted product from store shelves despite several statements that they were doing so.

Failure to cooperate with a recall notice is a serious offense. When it is a product that sickened so many children with a serious poison – it compounds the issue.

What is an FDA Warning Letter

An FDA Warning Letter is generated when the agency believes there are significant violations of federal requirements. Sometimes this is due to poor manufacturing processes. Other times it is due to health claims or incorrect directions for use.

Regardless of the reason, it requires action. Fairly immediate action.

The company must explain what they intend to do to correct the issue and a timeline to make it happen. Failure to do so can result in prohibiting the company from selling that product or others, depending on the nature of the offense.

Check Your Homes for Recalled Product

WanaBana, LLC issued an initial recall on October 30, 2024 for select apple cinnamon fruit pouches that was later updated to include all lots of those products on November 9, 2024.

The recall consisted of both WanaBana, Schnucks, and Weis brand products.

Recall:

WanaBana: apple cinnamon fruit puree pouches – all lots
Schnucks: cinnamon-flavored apple sauce pouches and variety packs – all lots
Weis: cinnamon apple sauce pouches – all lots

Recalled product remained on the store shelves long after the recall notice required its removal, so more lead-tainted product likely made its way into American homes.

Check your home for recalled product!

It is a good idea to check for blood lead levels if the product was consumed.

Lead Poisoning Causes Serious, Potentially Long-Term Health Concerns

Lead poisoning, particularly in children, can cause serious and potentially long-term health concerns. This is one of the reasons the FDA warns Dollar Tree in such a public and official manner.

There are no safe levels of lead in the blood that have been identified in children. Even low levels can cause developmental delays, difficulty learning, and behavior issues.

Lead exposure, especially consuming it in a tainted food, can cause serious adverse effects including:

Hearing and speech problems
Learning and behavior problems
Slowed growth and development
Damage to the brain and nervous system

This can translate to a lower IQ, under performance in school, and decreased ability to pay attention.

Unfortunately, there are usually no obvious signs or symptoms. In most cases, children do not get sick from exposure.

Parents who believe their child may have been exposed to lead should talk to a healthcare provider and have a blood lead test performed.

FDA Warns Dollar Tree in Official Warning Letter

In the official warning letter, the FDA explained the timeline for the recall in response to the blood lead outbreak. After multiple attempts to have the Dollar Tree stores removed the product from shelves, the store failed to do so.

The significant issue is that Dollar Tree “knowingly” left recalled products out for sale for weeks.

According to the letter:

“On October 29, 2023, Wanabana USA initiated a voluntary recall of all WanaBana Apple Cinnamon Fruit Puree pouches. As a consignee of the recalled products, Dollar Tree Inc. (Dollar Tree or you) was notified in writing, on October 29, 2023, of Wanabana USA’s volunatery recall of Apple Cinnamon Fruit Puree pouches. Subsequent recall audit checks of your Dollar Tree and Family Dollar/Dollar Tree combination stores (collectively referred to as your ‘Dollar Tree stores’) revealed that you continued to offer the recalled WanaBana Apple Cinnamon Fruit Puree pouches on store shelves well after the recall was initiated, despite FDA’s numerous attempts to bring this serious issue to your attention.”

Multiple reports from state and local partners indicated that recalled products remained on store shelves.

Product Remained on Shelves

Dollar Tree, along with all other retailers who received recalled product, were instructed to remove the product from the store and destroy it.

Stopping Sale at Checkout Was Not Sufficient

At least for one location, it appeared that the store simply placed a “stop sale” in the computer system. A measure meant to flag recalled product at checkout. This would prevent someone from checking out and leaving with the recalled product.

In November 2023, a consumer reported that they were shopping with their child at a Dollar Tree Store in Kitsap County, Washington. The consumer allowed their child to eat a food pouch off the shelf before paying but was stopped at the register when the consumer tried to pay for it. At checkout, consumer was notified that the product their child just ate was part of a recall. The consumer notified Kitsap County Public Health, which in turn notified the FDA. Dollar Tree was made aware of the situation in a phone call.

In response, Dollar Tree forwarded an email notification that was sent to stores on November 22, 2023 indicating that stores should remove all units from the sales floor, identify them in the stockroom, and destroy them.

That, however, did not take place.

Additional Audits Showed Recalled Product Available for Purchase

According to an FDA audit on the store sales system, dozens of attempted sales of recalled WanaBana products were made between November 24 and November 30, “further demonstrating that the recalled product remained on store shelves.”

Reports of recalled products making their way into consumer hands from state partners as well as audit checks found that recalled products were still available to consumers into December.

FDA Requires a Corrective Action

As with any FDA Warning Letter, corrective action must be documented to put systems in place to prevent the problem from happening again.

These corrective actions must include research into the root cause of the problem. This is important in implementing appropriate corrective actions. Corrective action should not only apply to the particular issue at hand, but how future issues can be avoided and addressed.

So far, Dollar Tree has failed to do this. An FDA Warning Letter puts a firm deadline on this activity.

“At various times following calls with FDA, you provided information regarding corrective actions and additional actions taken to effectuate this particular recall. However, to date, you have not provided FDA with any information demonstrating long-term, sustainable corrections have been implemented throughout your organization to prevent adulterated food from being received in interstate commerce and subsequently offered for sale in the future.”

The FDA has not found Dollar Tree’s response to be acceptable and is enforcing their jurisdiction to enforce the Warning Letter.

Has Your Child Consumed Recalled WanaBana Products from Dollar Tree?

Have you, your child, or a loved one consumed recalled WanaBana products from Dollar Tree? You may have questions about what to do next. An experienced Food Poisoning lawyer can help you determine if you have a legal case navigate the legal process to get what you deserve.