Cetirizine (Generic Zyrtec) Allergy Medication Recall

Cetirizine (Generic Zyrtec) Allergy Medication Recall

Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals, has issued a voluntary nationwide recall of four lots of cetirizine hydrochloride tablets USP 5 mg — a generic version of the allergy medication Zyrtec — after discovering possible cross-contamination with ranitidine, an unrelated heartburn and stomach-acid medication. The issue surfaced when a pharmacy technician noticed a red dot on some tablets while counting and dispensing them, and further inspection found some tablets were discolored. 

The recalled product was distributed nationwide in HDPE bottles of 100 tablets under NDC 16571-401-10, with affected lot numbers GY825029 through GY825032, all carrying an October 2028 expiration date. The recall was announced July 18 and publicized by the FDA this week, and the company has notified its distributor, Rising Pharma Holdings, which is arranging returns of the affected product. 

The FDA's core concern is for consumers who are hypersensitive to ranitidine's ingredients: if they unknowingly ingest contaminated cetirizine, they could experience serious adverse reactions, including anaphylaxis. 

Symptoms could include low blood pressure, difficulty breathing, trouble swallowing, swelling of the face and throat, hives, intense itching, and even loss of consciousness — all potentially life-threatening without prompt treatment. Importantly, the FDA and the company both note that, as of the announcement, no adverse events or injuries have actually been reported in connection with the recall — this is a precautionary action based on the contamination finding itself, not confirmed harm. Consumers are advised to check their medicine cabinets for the specific bottle and lot numbers and to stop use and contact their pharmacy or doctor if they have concerns, particularly if they have a known sensitivity to ranitidine or related stomach-acid medications. 

Health officials emphasize this is a targeted recall of specific manufacturing lots, not the entire cetirizine/Zyrtec product line.