Silver Spring, Maryland — Federal health officials are warning consumers to check their medicine cabinets after a popular allergy medication was voluntarily recalled because of potentially life-threatening cross-contamination with another prescription drug.
According to the U.S. Food and Drug Administration (FDA), Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., has recalled four lots of Cetirizine Hydrochloride Tablets USP, 5 mg, after testing revealed contamination with ranitidine, a medication commonly used to treat heartburn.
The agency says the contamination could pose a serious health risk for certain consumers.
FDA Warns of Potentially Serious Health Risks
The FDA said individuals who are hypersensitive to ingredients found in ranitidine could experience severe allergic reactions, including potentially life-threatening complications.
Possible symptoms include difficulty breathing, swelling of the face or throat, trouble swallowing, low blood pressure, hives and even loss of consciousness.
The agency warned that the contamination creates “a reasonable probability” of serious adverse health consequences for susceptible individuals.
“For consumers with a hypersensitivity to the ingredients in ranitidine, there is a reasonable probability that ingestion of Cetirizine tablets contaminated with ranitidine could result in serious adverse health consequences,” the FDA said.
So far, the manufacturer said no adverse events have been reported in connection with the recalled medication.
How the Contamination Was Discovered
According to the recall notice, the issue came to light after a pharmacy technician noticed unusual red dots and discoloration on several Cetirizine tablets while counting them during the dispensing process.
The observation prompted further investigation, ultimately leading to the voluntary nationwide recall. The affected product includes HDPE bottles containing 100 tablets with NDC number 16571-401-10.
Consumers who have the recalled medication are encouraged to verify the packaging information and avoid using the affected tablets.
Why Ranitidine Raises Concerns
Ranitidine, once widely sold under the brand name Zantac, was among the most commonly used medications for reducing stomach acid.
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However, it was removed from the U.S. market in 2020 after regulators raised concerns that certain formulations contained NDMA, a substance classified as a probable human carcinogen.
Although a reformulated version of ranitidine later returned to the market in 2025, the FDA says it should not be present in Cetirizine allergy medication.
What Consumers Should Do Next
Unique Pharmaceutical Laboratories has notified its distributor, Rising Pharma Holdings Inc., which has begun informing distributors and customers about the recall while arranging returns of the affected products.
Consumers who have questions can contact Rising Pharma Holdings Inc. directly for additional recall information.
Anyone who believes they experienced an adverse reaction after taking the recalled medication should seek medical attention immediately and report symptoms to their healthcare provider.
The FDA also encourages consumers to stop using any recalled product until further guidance is provided.
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