Popular allergy medication recalled due to potentially life-threatening cross contamination
Unique Pharmaceutical Laboratories recalled four lots of Cetirizine Hydrochloride Tablets USP, 5 mg, due to contamination with ranitidine.
A pharmaceutical company has voluntarily recalled a popular allergy medication after it was found to be cross-contaminated with an over-the-counter heartburn drug.
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According to a notice from the U.S. Food and Drug Administration (FDA), Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd. based in Panoli, Gujarat, India, recalled four lots of Cetirizine Hydrochloride Tablets USP, 5 mg, due to contamination with ranitidine.
The FDA warned that consuming the contaminated tablets could be life-threatening. It can cause severe hypersensitivity reactions and anaphylaxis including hypotension, difficulty swallowing, breathing, swelling of the throat or face, hives and loss of consciousness.
"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.
The company said it has not received any reports of adverse events related to the recall.
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Ranitidine, best known under the brand name Zantac, was once one of the most commonly used medications to reduce stomach acid.
However, it was pulled from the U.S. market in 2020 after regulators raised concerns over contamination with a probable human carcinogen. A reformulated version of the drug was later approved by regulators in 2025.
According to the recall notice, the contamination was discovered after a pharmacy technician noticed red dots and discoloration on some Cetirizine Hydrochloride tablets while counting them during dispensing.
The recall affects HDPE bottles containing 100 tablets (NDC: 16571-401-10).
Unique Pharmaceutical Laboratories has notified its distributor, Rising Pharma Holdings Inc., which has in turn notified distributors and direct customers by email and is arranging for the return of all recalled products.
Consumers with questions about the recall can contact Rising Pharma Holdings Inc. by phone at 1-844-874-7464 or by email at pv@risingpharma.com or qa@risingpharma.com.
Anyone who believes they experienced an adverse reaction after taking the recalled medication should contact their physician or healthcare provider.
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