Antihistamine recall across the U.S. triggered by heartburn drug contamination risk, FDA says

A generic version of the brand-name allergy medication Zyrtec is under recall across the U.S. due to potential cross-contamination with a heartburn drug, according to the Food and Drug Administration. 

Drugmaker Unique Pharmaceutical Laboratories is voluntarily recalling antihistamine drugs, commonly used to treat seasonal allergies, over potential cross-contamination with ranitidine, a heartburn drug. Unique Pharmaceutical Laboratories announced the recall on July 18. 

A pharmacy technician observed what they described as a red dot on some of the antihistamine drugs — cetirizine hydrochloride tablets USP 5 mg — when counting and bottling the medications, according to the FDA’s recall notice. Other tablets were discolored, alerting the technician to a possible issue. 

The FDA indicated that consumers who are hypersensitive to ingredients contained in ranitidine could experience adverse side effects upon exposure, including hypotension, shortness of breath, difficulty swallowing, loss of consciousness and other life-threatening reactions. 

There have been no reports of adverse events related to the recall, according to the FDA. 

What products are affected? 

The tablets, distributed by Rising Pharma Holdings Inc. to retailers across the U.S., are packaged in 100-tablet bottles. Products with the following lot numbers, set to expire in October 2028, are under recall:

• GY825029
• GY825030
• GY825031
• GY825032

Rising Pharmaceutical Holdings has notified its customers about the recall and is arranging for the return of all drugs that are under recall. 

Consumers with questions can contact Rising Pharma Holdings directly at 1-844-874-7464, or by email at  [email protected]  or [email protected]. Patients are encouraged to reach out to their healthcare provider if they experience problems related to the potentially contaminated drugs.