FDA Recalls 4 Cetirizine Lots Over Ranitidine Risk as Tablets Showed Red Spots
Updated
Updated · Fox Business · Jul 21
FDA Recalls 4 Cetirizine Lots Over Ranitidine Risk as Tablets Showed Red Spots
3 articles · Updated · Fox Business · Jul 21
Summary
Four lots of 5-mg cetirizine hydrochloride tablets in 100-count bottles were pulled nationwide after the FDA said they may be cross-contaminated with ranitidine.
A pharmacy technician spotted red dots and discoloration while counting tablets, leading regulators to warn that consumers hypersensitive to ranitidine ingredients could face anaphylaxis and other serious reactions.
Unique Pharmaceutical Laboratories, a J.B. Chemicals unit in India, initiated the voluntary recall on July 18 and said it has received no adverse-event reports.
The affected lots—GY825029, GY825030, GY825031 and GY825032—carry NDC 16571-401-10 and expire in October 2028; distributor Rising Pharma was notified.
Ranitidine, once sold as Zantac, was removed from the U.S. market in 2020 over carcinogen concerns, though a reformulated version won FDA approval in 2025.