Generic Zyrtec Recalled Over Ranitidine Contamination Risk July 23

Unique Pharmaceutical Laboratories is voluntarily recalling four lots of generic cetirizine hydrochloride tablets after discovering potential cross-contamination with ranitidine, a heartburn medication. A pharmacy technician spotted red dots and discolored tablets while dispensing the allergy drug on July 18. Consumers hypersensitive to ranitidine face risk of severe reactions including anaphylaxis, low blood pressure, and difficulty breathing. No adverse events have been reported to date.

What triggered the recall

A pharmacy technician noticed red dots and discoloration on cetirizine tablets while counting and bottling them for a prescription, according to the FDA. The technician’s observation led to investigation and discovery of cross-contamination with ranitidine, a drug used to treat heartburn and acid reflux. Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., announced the recall on July 18, and the FDA published it on July 20.

Which products are affected

The recalled product is Cetirizine Hydrochloride Tablets USP 5 mg, packaged in 100-tablet HDPE bottles with National Drug Code 16571-401-10. Four lot numbers are under recall: GY825029, GY825030, GY825031, and GY825032. All affected tablets expire in October 2028. Rising Pharma Holdings Inc. distributed the product nationwide to wholesalers and retailers.

Health risks for consumers

Consumers with hypersensitivity to ranitidine ingredients face a reasonable probability of serious adverse events if they ingest contaminated cetirizine tablets, according to the FDA. Potential reactions include anaphylaxis, low blood pressure, difficulty breathing, difficulty swallowing, throat and facial swelling, generalized itching, hives, and loss of consciousness. The FDA warns these reactions can be life-threatening. Unique Pharmaceuticals has not received any reports of adverse events related to the recall as of July 22.

What consumers should do

Check the lot number, NDC, and expiration date on your cetirizine bottle to determine if it is affected. Consumers with recalled products should stop using them immediately and contact the pharmacy where they were purchased for return or replacement instructions. Rising Pharma Holdings can be reached at 1-844-874-7464 Monday through Friday from 8 a.m. to 5 p.m. EST, or via email at [email protected] or [email protected]. Anyone experiencing health problems after taking the recalled medication should contact a physician.

Final Thoughts

The cetirizine recall affects only four specific lot numbers expiring October 2028. No injuries have been reported. Consumers should verify their bottle’s lot number and contact their pharmacy if affected.

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