The recall was initiated by Unique Pharmaceutical Laboratories and published by the FDA on July 20.
According to the FDA’s recall notice, the contamination issue was discovered by a pharmacy technician who noticed unusual markings—including red dots and discolored tablets—while filling a prescription.
The 5 mg cetirizine hydrochloride tablets are packaged in high-density polyethylene bottles of 100 tablets.
The four recalled lots—GY825029, GY825030, GY825031, and GY825032—are labeled under the National Drug Code (NDC) 16571-401-10. They have an expiration date of October 2028.
The FDA warned that people who are allergic or hypersensitive to ranitidine or its ingredients could experience severe, potentially life-threatening reactions if they consume the contaminated cetirizine tablets. The reactions may include anaphylaxis, difficulty breathing or swallowing, swelling of the face or throat, low blood pressure, hives, itching, or loss of consciousness.
To date, Unique Pharmaceuticals has not received any reports of adverse events linked to the affected products.
The company, a division of J.B. Chemicals & Pharmaceuticals Ltd., is headquartered in Panoli, Gujarat, India. The tablets were distributed nationwide through wholesale and retail channels by Rising Pharma Holdings Inc. The distributor has alerted customers by email and is coordinating the return of the affected medication.
Consumers who have the tablets should check the bottle's NDC, lot number, and expiration date to determine whether their medication is included in the recall.
Additionally, consumers with affected products should stop using the tablets immediately and contact the pharmacy where they were purchased for instructions on returning or replacing the medication.
Consumers with questions about the recall should contact the company. Anyone who experiences health problems after taking the recalled medication should contact a physician or other healthcare provider. Suspected adverse reactions may also be reported to the FDA's MedWatch program.
The FDA has noted that the recall affects only the specific generic 5 mg tablets in the listed lots. It does not apply to brand-name Zyrtec or other cetirizine products.
Most recalls that are regulated by the FDA are initiated by manufacturers or distributors after they discover a problem, such as contamination, labeling errors, manufacturing defects, or reports of adverse events. The company notifies the FDA, and the agency then coordinates with the company to evaluate the recall and communicate the risk to the public.