Overview
- The recall began after a U.S. pharmacy technician noticed red dots and discoloration on cetirizine tablets, prompting Unique Pharmaceutical Laboratories to notify its U.S. distributor on July 18 and withdraw four lots.
- The affected product is Cetirizine Hydrochloride Tablets USP 5 mg in 100-count HDPE bottles, NDC 16571-401-10, lots GY825029, GY825030, GY825031 and GY825032, all expiring October 2028.
- Rising Pharma Holdings has told its distributors and customers by email and is arranging returns of the recalled bottles that were distributed nationwide to wholesalers and retailers.
- News outlets report follow-up LC‑MS testing traced the contamination to ranitidine and that two lots failed lab checks, but those test details are reported by media and are not fully documented in the FDA or company recall notice.
- Officials warn that undeclared ranitidine could cause severe hypersensitivity or life‑threatening anaphylaxis in people allergic to ranitidine ingredients and direct consumers to contact Rising Pharma, their health care provider, or FDA MedWatch if they have concerns.