Unique Pharmaceutical Laboratories is recalling over-the-counter cetirizine hydrochloride allergy tablets across the United States after testing revealed potential contamination with ranitidine. Millions of Americans are being urged to check their medicine cabinets and avoid consuming the affected medication.
The recalled cetirizine hydrochloride tablets, commonly known by the brand name Zyrtec, were sold nationwide at major retailers. They were distributed in 100-tablet white plastic bottles, each containing five milligrams of cetirizine.
Unique Pharmaceutical Laboratories stated that it has received no reports of illness linked to the product to date. The company is organizing a recall of all affected lots, and officials advise anyone who experiences complications to contact their physician.
The health alert involves four specific lots of five-milligram cetirizine tablets: GY825029, GY825030, GY825031 and GY825032. All four lots are set to expire by October 2028, and a complete list of recalled products is available on the FDA website.
Risks of ranitidine cross-contamination
Ranitidine, commonly known by the brand name Zantac, is a medication used to reduce stomach acid. It was banned in the United States in 2020 due to concerns over the cancer-linked chemical NDMA, but was re-approved in 2025 after being reformulated.
Health officials warned that cross-contamination could trigger a serious adverse reaction in people with a sensitivity to ranitidine ingredients. Warning signs include low blood pressure, shortness of breath, difficulty swallowing, throat and facial swelling, itchy skin, a rash and loss of consciousness.
In serious cases, patients can develop anaphylaxis, a life-threatening condition where the airways become blocked, leaving someone struggling to breathe. Although previous research suggests that allergies to ranitidine are rare, health authorities warned of significant risks for sensitive individuals.
"For consumers with a hypersensitivity to the ingredients in ranitidine, there is a reasonable probability that ingestion of cetirizine tablets contaminated with ranitidine could result in serious adverse events," the FDA said.
Discovery and distribution details
Investigators said the issue was discovered after a pharmacy technician noticed discrepancies while counting tablets during dispensing. The technician found that some tablets appeared to have a red dot, while others were discolored or had multiple red-colored spots.
The FDA said the recalled drug was cross-contaminated, suggesting that small amounts of another drug were mixed in during the manufacturing process. This can occur when the same equipment is used for different medications. Unique Pharmaceutical Laboratories, based in India, manufactured the tablets.
The drug was distributed in the United States through Rising Pharma Holdings, which is also seeking the return of the medication. Anyone with questions regarding the recall is asked to contact Rising Pharma Holdings directly.
Nearly 90 million adults in the United States, or one in three, suffer from seasonal allergies. Seasonal allergies occur when the immune system overreacts to pollen, leading to symptoms such as sneezing, coughing and watery eyes. Cetirizine is an antihistamine that treats these symptoms by helping to calm the immune system.
