Millions of Americans are advised to check their medicine cabinets for potential contamination in a widely used over-the-counter allergy medication. Unique Pharmaceutical Laboratories has recalled its cetirizine hydrochloride tablets, commonly sold under the brand name Zyrtec, due to the possibility that they may contain ranitidine.
Ranitidine, previously known by the brand name Zantac, is a medication used to reduce stomach acid. While it was banned in the U.S. in 2020 over concerns about containing the cancer-linked chemical NDMA, it was re-approved in 2025 after reformulation. Health officials have cautioned that the presence of ranitidine in the recalled allergy medication could trigger a life-threatening adverse reaction in individuals sensitive to its ingredients. Symptoms of such a reaction can include low blood pressure, swelling, and loss of consciousness.
The recalled medication consists of 100-tablet white plastic bottles containing five milligrams of cetirizine hydrochloride. These products were distributed nationwide and available at major retailers. Unique Pharmaceuticals reported that it has not received any reports of illnesses linked to the recalled medication to date. The company is coordinating the return of all affected products.
Four specific lots of the drug, manufactured by an India-based company and distributed in the U.S. by Rising Pharma Holdings, have been identified in the recall: GY825029, GY825030, GY825031, and GY825032. These lots are set to expire in October 2028. A comprehensive list of the recalled products can be found on the FDA website.
The issue came to light when a pharmacy technician observed discrepancies while dispensing the tablets, noting that some appeared discolored or had red spots. The FDA stated that the drug was "cross-contaminated," suggesting that small amounts of another drug were mixed in during the manufacturing process, possibly due to the use of shared equipment. While the prevalence of ranitidine allergy is considered rare, the FDA warned of the potential for serious adverse events in consumers with a hypersensitivity to ranitidine's ingredients.
Individuals experiencing any complications after taking the recalled medication are advised to contact their physician. Those with questions regarding the recall should reach out to Rising Pharma Holdings. Warning signs of a reaction to ranitidine include low blood pressure, shortness of breath, difficulty swallowing, swelling of the throat and face, itchy skin, rash, and loss of consciousness. In severe cases, anaphylaxis, a life-threatening condition where airways become blocked, can occur.