Rising Pharma Holdings has voluntarily recalled four lots of 5 mg cetirizine hydrochloride tablets (100-count) due to possible ranitidine cross-contamination. Recalled products carry NDC 16571-401-10, expire 10/2028, and include lot numbers GY825029–GY825032. While no adverse events have been confirmed, those allergic to ranitidine may face serious reactions, including anaphylaxis. Consumers should check their bottles, stop using affected lots, and contact Rising Pharma or report issues to FDA MedWatch.
Cetirizine Tablets Voluntarily Recalled Over Possible Ranitidine Contamination — Check Lot Numbers and Stop Use If Affected
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A voluntary recall has been issued for four lots of 5 mg cetirizine hydrochloride tablets after possible cross-contamination with ranitidine was discovered, a company notice says. The affected product was packaged in 100-count bottles and distributed across the United States.
What Happened
On July 18, Rising Pharma Holdings Inc., a New Jersey-based distributor, announced the recall of four lots of cetirizine hydrochloride tablets manufactured by Unique Pharmaceutical Laboratories in India. The issue was identified when a pharmacy technician noticed a red dot on several tablets while counting pills, prompting further investigation and the voluntary recall.
Risk And Who Is Affected
The concern is possible cross-contamination with ranitidine, a medication used for heartburn and acid indigestion. Although Unique Pharmaceutical Laboratories reports no confirmed adverse events to date, the recall warns that people with hypersensitivity to ranitidine could experience serious adverse reactions, including anaphylaxis. Anaphylaxis can be life-threatening and may include symptoms such as difficulty breathing or swallowing and loss of consciousness.
How To Identify Recalled Bottles
- National Drug Code (NDC): 16571-401-10
- Dosage and Pack: 5 mg tablets, 100-count bottles
- Expiration Date: 10/2028
- Recalled Lot Numbers: GY825029, GY825030, GY825031, GY825032
What Consumers Should Do
If you have cetirizine hydrochloride at home, check the bottle label now for the NDC, expiration date, and lot number. If your product matches the recalled lots, stop using it immediately and follow the distributor's return instructions. If you suspect you have experienced a reaction after taking the medication, seek medical attention right away.
Consumers can report side effects or product quality problems to the U.S. Food and Drug Administration through the MedWatch Adverse Event Reporting program online, by mail, or by fax.
Company Contact And Next Steps
Rising Pharma Holdings Inc. is coordinating the return of affected product. For questions or medical concerns, the company can be reached Monday through Friday, 8 a.m. to 5 p.m. Eastern at 1-844-874-7464 or by email at [email protected] or [email protected]. Regulators and pharmacies continue to monitor the situation as the companies work to retrieve the potentially contaminated tablets and prevent further distribution.
Although no adverse reactions have been reported so far, the recall highlights ongoing vulnerabilities in parts of the pharmaceutical supply chain and serves as a reminder to routinely check medication packaging and recall notices.
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