Seasonal allergy medicine is a staple in many U.S. households, especially during summer when over-the-counter and generic antihistamines are in regular use. That is why a new FDA-linked recall is getting attention nationwide. The recall involves generic cetirizine hydrochloride tablets, a common version of Zyrtec, that were distributed to retailers across the country.
The recall involves four lots of allergy tablets
Unique Pharmaceutical Laboratories announced a voluntary recall on July 18 for cetirizine hydrochloride tablets USP 5 mg, according to the FDA recall notice. The affected medicine was distributed by Rising Pharma Holdings Inc. in 100-tablet bottles to retailers across the U.S. Four lot numbers are included in the recall: GY825029, GY825030, GY825031, and GY825032.
The recalled bottles all carry an expiration date of October 2028, according to the FDA notice. The issue came to light after a pharmacy technician reported seeing a red dot on some tablets while counting and bottling the medication. The notice also said other tablets appeared discolored, which raised concern about a possible product problem.
What is confirmed across the U.S. right now
What is confirmed is that the recall is nationwide and applies to retailers across the United States. Rising Pharma Holdings has notified its customers and is arranging for the return of the recalled drugs, according to the FDA notice. The company has not released a full public list of affected retail locations or states where the bottles were sold.
That means shoppers may not yet have a store-by-store breakdown of where the product was stocked. What is publicly identified so far is the product type, the bottle size, the four lot numbers, and the October 2028 expiration date. The FDA notice also stated there have been no reports of adverse events related to this recall so far.
Why the tablets were recalled and what shoppers should know
The reason for the recall is potential cross-contamination with ranitidine, a heartburn drug, according to the FDA notice. The agency said consumers who are hypersensitive to ingredients in ranitidine could face serious reactions after exposure. Those possible effects include hypotension, shortness of breath, difficulty swallowing, loss of consciousness, and other life-threatening reactions.
For shoppers, the practical takeaway is that the recall is limited to specific bottles of generic cetirizine 5 mg packaged in 100-count containers. Rising Pharma Holdings said it is managing returns of the recalled medication through its customers. As of the FDA notice tied to the July 18 announcement, no adverse events had been reported.
