Nearly 8,000 Bottles of a Trusted Allergy Medicine Have Been Recalled Nationwide

National data has suggested that 65 million American adults, or one-quarter of the population, are currently living with seasonal allergies. That’s separate from factors like food sensitivities or even effects of weather disasters, all of which combined make antihistamines one of the most commonly used over-the-counter medication categories.

If a pink liquid or pill saves you when those symptoms strike or you opt for a generic that urges you to “compare to the active ingredients” in a popular name brand, a recent U.S. Food and Drug Administration (FDA) notice reveals that a widely-used antihistamine product is under recall for a production problem that could lead to administration errors for consumers.

First announced on December 12, the recall affects nearly 8,000 bottles of diphenhydramine hydrochloride, also known as diphenhydramine HCI—the generic form of Benadryl. The drug is used to alleviate hay fever symptoms like sneezing, runny nose, itchy eyes, upper airway irritation, as well as other signs of seasonal allergies and the common cold. Some veterinarians recommend it for some pet conditions, though it should always be administered under the care of a credentialed veterinary professional.

The recall resulted from a manufacturing error in which the capsules were misprinted with the wrong identifying code. Some sources, such as Harvard Medical School’s site, suggest an error of this nature could cause dosing issues or medication confusion for anyone who uses those codes to distinguish which medication they are taking.

The misprinted capsules were distributed by Akron Pharma, a Fairfield, NJ-based company. These were sold “nationwide in the U.S.,” according to the FDA’s report, in 100- and 1,000-capsule bottles of 25-milligram (mg) and 50-milligram doses, all bearing an expiration date of September 30, 2026. A total of 7,978 bottles bearing three lot numbers were implicated in the recall:

• Lot Number: KDC0124001A (7,198 bottles)
• Lot Number: KDC0124002B (456 bottles)
• Lot Number: KDC0224001B (324 bottles)

It is not clear what color the pills nor their bottle were.

Diphenhydramine HCI works by binding to H1 receptors in the body, thereby blocking the effects of chemicals known as histamines, which are released by the immune system in response to allergens. Though the drug is generally considered safe to take, the Cleveland Clinic notes that it can still cause “significant problems” when administered incorrectly. “The main possible complication is overdose (antihistamine toxicity),” Clinic experts note.

A January 10 update to the FDA’s notice labelled the incident a “Class III” event, dubbing this “a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.” With this, the FDA suggests that since there was no error in the drug’s formulation, those who take the drug using the label’s recommended dosages are unlikely to experience adverse health effects.

This was not the only drug manufactured by Akron Pharma that was subject to recall due to misprinted drug IDs. On the same date, the company also recalled over 20,000 bottles of acetaminophen, the generic form of TYLENOL.

Those who have purchased either drug should consult their doctor or pharmacist to determine next steps, and contact the maker for possible steps toward refund.

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