The United States Consumer Product Safety Commission (CPSC) has issued a recall for 100-mL bottles of Benadryl Liquid Elixir, identifiable by the X003VRIGUL label. This action comes in response to safety concerns regarding child-resistant packaging.
As reported by People, on March 20, the CPSC revealed that approximately 2,300 bottles of this allergy medication lack the necessary child-resistant packaging. This oversight raises significant safety concerns, particularly the risk of poisoning among young children.
The presence of diphenhydramine—an antihistamine featured in the product—highlights the importance of adhering to the Poison Prevention Packaging Act (PPPA), which mandates such packaging for these kinds of medications. The CPSC emphasized the following:
“The Benadryl contains diphenhydramine, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The packaging of the products is not child-resistant, posing a risk of poisoning if the contents are swallowed by young children.”
According to resources from MedlinePlus, diphenhydramine can pose serious health risks to children. Therefore, it is crucial to administer age-appropriate medications. Adult formulations can lead to severe side effects, even fatalities, in young populations.
The recalled 2,300 bottles, sold on Amazon between July 2023 and October 2024, were priced between $16 and $19. The CPSC has assured consumers of a full refund.
Background on the Poison Prevention Packaging Act
Established in 1970 under President Richard Nixon’s administration, the Poison Prevention Packaging Act (PPPA) aims to protect children aged five and younger from accidental ingestion of toxic substances. The law mandates that hazardous products, including prescription and over-the-counter medications, as well as household chemicals, must feature child-resistant packaging.
The PPPA has successfully reduced the incidence of child fatalities caused by such products by approximately 1.4 deaths per million, benefiting not just children but also the elderly and those with disabilities.
Insights from Kenvue Regarding the Recall
Kenvue, the parent company of notable brands like Benadryl, Aveeno, Johnson’s, and Zyrtec, has responded to the recall situation. A spokesperson emphasized their commitment to product quality, packaging integrity, and safety, asserting an ongoing investigation into the issue.
“We take the quality, packaging, and safety of our products very seriously, and always recommend medication be kept out of the reach of children. We are investigating this matter as the recalled lot of Benadryl Liquid Elixir is not authorized for sale in the United States.”
The company clarified that the recalled product originated from Canada, meeting local regulations, and speculated that it might have been sold illegally in the U.S. by unauthorized sellers on platforms like Amazon.
“Benadryl Liquid Elixir 100 ml bottle is a product manufactured in Canada for Canadian consumers and meets Health Canada’s packaging regulations. It appears this product may have been diverted from Canada and inappropriately sold in the United States by an unauthorized third-party online seller.”
Kenvue assured that all other Benadryl products available in the U.S. meet safety standards when used according to the label directions.
“This recall does not impact any other Benadryl product sold in the United States or Canada. Benadryl is safe when taken as indicated on the product label.”
Consumers who purchased the recalled product can receive a full refund by submitting their Amazon order number along with a photo of the discarded medicine to [email protected].