Data show more than 50 million Americans may combat allergy symptoms, but an agency says an over-the-counter drug's bottle puts some at risk.
2,300 Bottles of a Trusted Allergy Medicine Were Just Recalled for Federal Violation
Published on Mar. 20, 2025
Editor’s note: The afternoon of Friday, March 21, 2025, a spokesperson at Kenvue, the manufacturer of Benadryl, responded to this article by providing the statement below.
With 24.5 million Americans dealing with seasonal allergies, says the Allergy & Asthma Network, and around that same number experiencing food allergies, a 2021 survey found that at least half of U.S. adults with allergies take over-the-counter antihistamines such as Benadryl, Claritin, and Allegra to help manage their reactions.
If your go-to relief is the well known pink brand, on March 20, the U.S. Consumer Product Safety Commission (CPSC) announced the recall of an estimated 2,300 100-milliliter bottles of Benadryl Liquid Elixir, “which must be in child-resistant packaging as required by the Poison Prevention Packaging Act,” the CPSC says. “The packaging of the products is not child-resistant, posing a risk of poisoning if the contents are swallowed by young children.”
Diphenhydramine, the active ingredient that requires Benadryl to follow the PPPA, is an antihistamine that treats allergy symptoms.
The recall notice also highlights: “Only the bottle is being recalled, not the medicine itself, but both should be disposed of. All known purchasers are being contacted directly.”
The affected products were reportedly sold exclusively on Amazon.com from July 2023 through October 2024.
The recalled Benadryl is sold in a rounded bottle which itself is dark in color, with the classic Benadryl pink and white palette. Other packaging details:
- Benadryl printed in blue text on the front of the label
- Bottles were packaged inside a pink and white box, also with Benadryl printed in blue
- Additionally, the product has a white label on the bottom with this code printed in black: X003VRIGUL
- According to the recall notice, these products were manufactured in Canada and imported by Arsell Inc., of Brooklyn, New York
A spokesperson at Kenvue stated via email on Friday:
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.
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.
Consumers who have purchased this lot of product from Amazon should comply with the details of the recall, which can be found on the Consumer Product Safety Commission website.
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.
The CPSC notes that the Poison Prevention Packaging Act was enacted in 1970. It requires certain household items to be packaged in a way that makes it difficult for children under five years of age to quickly or easily open them. It applies to items like over-the-counter medicine and cleaning products and aims to prevent children from accidentally ingesting potentially harmful chemicals.
According to National Library of Medicine data from 2023, the PPPA has led to childhood death in those 5 years old or younger to decrease by 1.4 per million.
In children, the side effects of ingesting diphenhydramine can be severe and even fatal. The U.S. Food and Drug Administration (FDA) warns parents not to give children under 2 years old any antihistamines, as the child could experience convulsions, a fast heart rate, and death.
The FDA also advises parents to use caution when giving antihistamines to young children older than 2 years old, noting that such medicine could lead to an accidental overdose.
As of now, the recalled Benadryl products have not resulted in any incidents, according to the CPSC announcement.
If you believe your child has accidentally ingested the affected Benadryl product, immediately call the Poison Control hotline at 1-800-222-1222. Consumers in possession of an affected Benadryl Liquid Elixir bottle should contact importer Arsell at the contact details in the CPSC link and provide their Amazon order number (which could be available in your order history) and a photo that proves the affected product was thrown away.
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