The U.S. Food and Drug Administration (FDA) announced the voluntary recall of four lots of 5 mg cetirizine hydrochloride, a generic antihistamine equivalent to Zyrtec, after detecting a possible cross-contamination with ranitidine, a medication for stomach acidity that could trigger life-threatening allergic reactions in sensitive individuals.
The recall was issued on July 18 by Unique Pharmaceutical Laboratories, a division of J. B. Chemicals & Pharmaceuticals Ltd., based in Panoli, Gujarat, India, and affects a product distributed to wholesalers and retailers throughout the United States between April and June of this year.
According to the official notice from the FDA, laboratory tests detected traces of ranitidine—approximately less than 0.5%—in two of the four batches, prompting the preventive recall of all of them.
The risk is particularly serious for individuals with a known hypersensitivity to the ingredients in ranitidine: consuming a contaminated tablet could lead to severe adverse events such as severe hypersensitivity reactions, hypotension, shortness of breath, difficulty swallowing, throat and facial swelling, generalized itching, hives, loss of consciousness, and anaphylaxis, a body-wide allergic reaction that can be fatal within minutes.
The FDA describes the possible symptoms as "hypotension, dyspnea, difficulty swallowing, throat and facial swelling, generalized itching, hives, and loss of consciousness, all potentially fatal."
Ranitidine -marketed under the brand Zantac- was withdrawn from the U.S. market in April 2020 precisely because the FDA found that it contained levels of NDMA (N-nitrosodimethylamine), a substance classified as a probable human carcinogen, which increased over time during storage.
What is the affected product?
The recalled medication is packaged in bottles containing 100 high-density polyethylene tablets, with the NDC code 16571-401-10 and an expiration date of October 2028.
The four lots being withdrawn are:
- GY825029
- GY825030
- GY825031
- GY825032
The distributor of the product is Rising Pharma Holdings Inc., which marketed it nationally.
As of the date of the announcement, the manufacturing company stated that it had not received reports of adverse events related to this recall.
According to the FDA, a complaint was received regarding the product in which a pharmacy technician identified a discrepancy while counting the tablets at the time of dispensing. The appearance of a red spot was reported on the 5 mg cetirizine hydrochloride USP tablets, and some tablets showed discoloration (they appeared faded due to the presence of multiple red spots).
This recall adds to others that occurred in 2026, such as the withdrawal of a lot of the anxiolytic alprazolam in April due to dissolution failures, and the withdrawal of millions of bottles of eye drops that same month due to lack of sterility assurance.
What should consumers do?
Anyone with 5 mg cetirizine bottles at home bearing any of the mentioned lot numbers should stop using them immediately and contact Rising Pharma Holdings Inc. at 1-844-874-7464, available Monday to Friday from 8:00 am to 5:00 pm (Eastern Time), or write to pv@risingpharma.com or qa@risingpharma.com.
Adverse reactions can also be reported to the FDA's MedWatch program by calling 1-800-332-1088 or online at www.fda.gov/medwatch/report.htm.
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