Full Breakdown
Nationwide Recall of Cetirizine Hydrochloride Tablets Over Potential Ranitidine Contamination
7/22/2026, 2:42:21 AM
Recall Overview
On July 18, Rising Pharma Holdings Inc., a New Jersey-based distributor, announced a voluntary recall of four lots of 5-mg cetirizine hydrochloride tablets after a pharmacy technician identified a red dot on tablets that indicated possible cross-contamination with ranitidine. The tablets, sold in 100-count bottles, were manufactured by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., in India. No adverse events have been reported to date, but the FDA notice warns that hypersensitivity to ranitidine can trigger severe reactions, including anaphylaxis, low blood pressure, and loss of consciousness.
Background on Ranitidine and Cross-Contamination
Cetirizine hydrochloride is an antihistamine used for seasonal allergies and hives. Ranitidine, an acid-reducing drug, was previously withdrawn from the U.S. market in 2020 due to the presence of the probable carcinogen N-nitrosodimethylamine (NDMA). Although a reformulated ranitidine tablet received FDA approval last year, the substance remains a known allergen for some consumers.
Official Statements & Consumer Guidance
Rising Pharma Holdings Inc. advises customers who have taken the recalled product and have a known ranitidine sensitivity to contact their physician. The company also provides multiple channels for inquiries and adverse-event reporting: a toll-free line (1-844-874-7464), email addresses (pv@risingpharma.com, qa@risingpharma.com), and the FDA’s MedWatch program.
“Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product,” — Rising Pharma Holdings Inc
Recall Details and Distribution
The FDA’s recall list specifies the lot numbers GY825029, GY825030, GY825031, and GY825032, each with an expiration date of 10/2028. The affected bottles were distributed nationwide to wholesalers and retail stores. Rising Pharma Holdings Inc. has emailed impacted customers to arrange returns and has not yet disclosed the total number of bottles recalled. A follow-up inquiry on July 21 did not immediately yield a response from the company. Consumers are urged to verify the manufacturer, distributor, and lot number on their bottle and to discontinue use if any of the identified details match.
