The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of certain 5-milligram cetirizine hydrochloride tablets after a potential cross-contamination issue was identified. The affected medication was distributed across the United States and may contain traces of ranitidine, a drug previously used for ulcers and digestive conditions.
The recall involves products manufactured by Unique Pharmaceutical Laboratories and distributed by Rising Pharma Holdings Inc. Consumers who have the affected tablets are advised to dispose of them or return them to the place of purchase for possible refund or replacement. The FDA published the company’s recall notice on July 20, 2026, following the company announcement dated July 18, 2026.
Four Lots of Cetirizine Tablets Identified in the Recall
According to the FDA, the recalled product is Cetirizine Hydrochloride Tablets USP 5 mg, packaged in 100-count HDPE bottles with the National Drug Code (NDC) 16571-401-10. The affected bottles were manufactured by Unique Pharmaceutical Laboratories, a division of J. B. Chemicals & Pharmaceuticals Ltd., and distributed by Rising Pharma Holdings Inc.
The recalled lots are identified by the lot numbers GY825029, GY825030, GY825031, and GY825032. All affected products have an expiration date of October 2028. The tablets were sold at the consumer level through wholesalers and retailers nationwide.
The company began the voluntary recall after a product complaint was received from a pharmacy technician who noticed a discrepancy while counting tablets during dispensing. According to the FDA notice, some tablets showed red dots or discoloration linked to the possible presence of ranitidine contamination.
The medication is an antihistamine commonly used for allergy relief. The FDA notice states that the recall was initiated because of potential cross-contamination with ranitidine, which was not intended to be present in the cetirizine tablets.
Potential Health Risks and Steps for Affected Consumers
According to Unique Pharmaceutical Laboratories, consumers with sensitivity to ranitidine ingredients could face serious adverse reactions if they take contaminated tablets. The company listed possible reactions including severe hypersensitivity responses and anaphylaxis, which may involve symptoms such as low blood pressure, breathing difficulties, trouble swallowing, swelling of the throat or face, hives, and loss of consciousness.
To date, Unique Pharmaceuticals has not received reports of adverse events connected to the recall, according to the company statement shared by the FDA. Consumers who experience health concerns after taking the recalled medication are advised to seek medical attention and contact a healthcare provider.
Rising Pharma Holdings Inc. is handling consumer questions and returns related to the recall. The company can be contacted by phone at 1-844-874-7464 from Monday through Friday, 8 a.m. to 5 p.m. Eastern Time, or by email at [email protected] or [email protected].
The FDA also reminds consumers that adverse reactions or quality problems linked to medication can be reported through the MedWatch Adverse Event Reporting program. The recalled products remain subject to the FDA’s oversight as the return process continues.
