Cetirizine Allergy Tablets Recalled Over Contamination with Heartburn Drug

Rising Pharma Holdings Inc. is voluntarily recalling four lots of 5 mg cetirizine hydrochloride tablets, a generic equivalent of Zyrtec, after a pharmacy technician discovered potential cross-contamination with the heartburn medication ranitidine. The recall was announced on July 18.

The tablets, manufactured by Unique Pharmaceutical Laboratories in India and distributed nationwide in the U.S., are packed in 100-count bottles. The affected lot numbers are GY825029, GY825030, GY825031, and GY825032, all with an expiration date of October 2028 and National Drug Code No. 16571-401-10.

The problem came to light when a pharmacy technician counting and bottling the medications observed a red dot on some tablets and other discoloration. Follow-up investigation pointed to possible cross-contamination with ranitidine, a drug used to treat heartburn.

Consumers who are hypersensitive to ranitidine could face serious adverse events if exposed to the contaminated tablets. The recall notice warns that risks include hypotension, shortness of breath, difficulty swallowing, loss of consciousness, and other life-threatening reactions such as anaphylaxis. Despite these dangers, no adverse events related to the recall have been reported to date.

Rising Pharma Holdings is notifying its customers and arranging for the return of all recalled products. Patients are advised to check their medicine bottles for the recalled lot numbers and, if a match is found, to stop using the product. Consumers can contact Rising Pharma at 1-844-874-7464 Monday through Friday from 8 a.m. to 5 p.m. ET, or by email at [email protected] or [email protected] for return instructions. Anyone who believes they have experienced a reaction should contact a healthcare provider immediately. Adverse events or product quality problems can also be reported to the FDA’s MedWatch Adverse Event Reporting program.