Lead in Recalled Apple Sauce Pouches Linked to 64 Illnesses Among Children: FDA

The number of lead poisoning illnesses linked to recalled apple sauce pouches sold throughout the United States is rising at an alarming rate, as federal regulators continue investigate the exact source of the contamination.

The U.S. Food and Drug Administration (FDA) provided an update this week on it’s WanaBana, Weis, and Schnucks fruit pouch investigation, indicating that the agency has now become aware of at least 64 lead-related illnesses, each involving children under six years old from at least 27 different states, which appear to be linked to the contaminated apple sauce products.

The recalled apple sauce pouches were found to contain dangerously high lead levels of 2.18 parts per million (ppm), which is more than 200 times higher than the safe levels established by the FDA, and poses a serious risk of lead poisoning if consumed. Investigating officials conducted sample testing of the affected children’s blood and identified lead levels of at least 3.5 micrograms of lead per deciliter of whole blood (µg /dL), which is the child lead exposure level that the U.S. Centers for Disease Control and Prevention (CDC) recommends for medical intervention.

WanaBana, Weis, and Schnucks Fruit Pouch Recalls

FDA officials initially issued an advisory to consumers on October 28, which warned them to avoid children’s WanaBana apple cinnamon fruit puree pouches, after lead levels high enough to cause lead poisoning were detected in the products. The warning followed an investigation led by North Carolina health officials, which identified the fruit pouches as the potential lead exposure source of four children who suffered elevated blood levels and lead poisoning.

Due to the lead exposure and poisoning risks, the FDA issued a WanaBana fruit pouch recall October 31, indicating the agency had identified exceptionally high lead concentrations in several batches of the apple cinnamon variety through sample testing. At least seven adverse events were reported in relation to the lead contaminated products from consumers in multiple states at the time of the recall.

During the course of the investigation, the FDA expanded the recall to include additional products distributed by WanaBana that were sold under Weis and Schnucks brands, after investigators also identified elevated lead levels in several batches of Weis and Schnucks cinnamon-flavored fruit products.

To date, the recall now impacts all lots of all lots of 2.5 oz. WanaBana apple cinnamon fruit puree pouches sold in packs of three, 90g Weis cinnamon apple sauce pouches with lot number 05023:28, as well as Schnucks apple sauce 90g pouches with cinnamon with lot numbers 05023:19, 09023:22 and 09023:24.

The recalled WanaBana products were sold online and in stores nationwide through multiple retailers, including Amazon and Dollar Tree. Recalled Schnucks-brand products were distributed at Schnucks and Eatwell Markets grocery stores, while Weis-brand products were sold exclusively in Weis grocery stores.

Apple Sauce Lead Poisoning Investigation

Officials indicated in a prior investigation update released weeks ago that the number of lead poisoning illnesses that appeared to be linked to the lead-tainted fruit pouches had spiked to at least 34, which involved individuals from at least 23 different states. Since then that number has almost doubled.

At that time, the FDA states that sample testing revealed elevated lead levels only in products that contained cinnamon, and suspected that could be the lead contamination source. The tainted products were originally manufactured by Austrofood in Ecuador, then sold under WanaBana, Weis, and Schnucks brands. Officials are working with Ecuadorian authorities to obtain cinnamon samples for testing and to determine its source.

On November 30, the FDA indicated that Wanabana had determined through an internal investigation that the cinnamon was supplied by Negasmart, a third-party distribution company located in Ecuador.

In the latest investigation update, officials indicate that the FDA has initiated an onsite inspection of the Austrofood manufacturing facility, and is currently collecting ingredient samples for further testing. Additionally, it reported that Ecuadorian authorities had detected higher lead levels in Negasmart’s cinnamon than the country allows, and that the supplier is currently under an administrative sanction process to determine who is responsible for the contamination.

Investigators are still trying to determine the source of the contamination, and any other products that may be tainted with lead. Officials will update the public as more information becomes available.

Lead Poisoning Risks

Lead is a toxic heavy metal that can cause permanent brain damage, nervous system injuries, cognitive impairment, physical disabilities, or other long-term health consequences. Children are particularly vulnerable to lead exposure, as they are still developing and do not usually show exposure signs or symptoms.

Short-term lead exposure can cause minor symptoms, including headaches, abdominal pain, headaches, vomiting, or anemia, while longer exposure can result in more serious symptoms, including lethargy, confusion, tremors, or muscular exhaustion.

Pediatricians say there is no safe lead exposure level for children, and any exposure may increase the risk of developing severe or permanent injuries, or even death.

Research has shown that children with elevated blood lead levels scored lower on mathematical testing, and other research has indicated that childhood lead exposure can affect the brain’s structural integrity later in life.

A recent study also indicated that lead exposure during pregnancy can even impact an unborn baby’s cognitive skills and development after they are born. According to the findings of a report published in October, researchers found that prenatal lead exposure increased the risk of children having difficulty learning language, social skills, and retaining memory at two years old. The study participants also had higher instances of mental impairment and delayed development.