The recall of a popular allergy medication in the United States is raising health concerns after quality tests revealed that some of its vials may have been contaminated with another drug that could be life-threatening to some people.
Unique Pharmaceutical Laboratories has withdrawn several batches of Cetirizine Hydrochloride tablets, which are sold without a prescription to treat allergy symptoms, after discovering they may contain trace amounts of ranitidine, commercially known as Zantac, a drug used to reduce stomach acid.
The company explained that it has not yet received any reports of illnesses related to these products, but it called on consumers to stop taking the recalled tablets, and began procedures to recall the affected packages in cooperation with Rising Pharma Holdings, which distributes the drug in the United States.
The U.S. Food and Drug Administration (FDA) warned that the risk could extend to people who are allergic to the components of "ranitidine," as taking contaminated tablets could lead to a severe allergic reaction that could be life-threatening.
Signs of an allergic reaction include low blood pressure, shortness of breath, difficulty swallowing, swelling of the throat or face, itching, rash, and loss of consciousness. In severe cases, the patient may develop anaphylaxis, a severe allergic reaction that causes narrowing of the airways and difficulty breathing.
The Food and Drug Administration attributed the recall to accidental contamination that occurred during the manufacturing process, explaining that small amounts of another drug may mix when the same equipment is used to produce more than one drug product.
The problem was discovered after a pharmacy technician noticed a difference in the shape of some tablets during the counting process before dispensing them, as some had a red spot on them, while other tablets appeared to be discolored or had multiple red spots.
The recall included four batches of the drug bearing the numbers: GY825029, GY825030, GY825031 and GY825032, all of which expire in October 2028. These tablets were sold in white plastic containers of 100 tablets with a concentration of 5 milligrams per tablet, and were distributed to retail stores throughout the United States.
Cetirizine is a common allergy medication belonging to the antihistamine class, which helps relieve allergy symptoms such as sneezing, coughing, and watery eyes. It is used by many people with seasonal allergies, which affect approximately 90 million adults in the United States.
Ranitidine was withdrawn from the US market in 2020 due to concerns that it contained NDMA, a substance linked to cancer, before being re-approved for sale in 2025 after being reformulated.
