Cetirizine hydrochloride is being recalled after possible ranitidine contamination

Federal regulators on Monday announced the recall of a popular allergy drug over concerns it may have been contaminated with another drug, potentially causing a “life-threatening” reaction.

The US Food and Drug Administration (FDA) said certain Cetirizine hydrochloride tablets, commonly sold over the counter as generic versions of Zyrtec, are affected by the voluntary recall.

The recall was initiated Saturday by Unique Pharmaceutical Laboratories, a division of JB Chemicals & Pharmaceuticals Ltd., based in Panoli, Gujarat, India, according to the FDA.

The affected pills may be contaminated with ranitidine, a drug once widely used to reduce stomach acid production. Ranitidine, sold under the brand name Zantac, was removed from the US market in 2020 after regulators raised concerns about human carcinogen contamination. A reformulated version of the drug was later approved by regulators in 2025.

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The FDA warned that some consumers may experience “serious adverse events,” including anaphylaxis, a rapid allergic reaction that can be life-threatening.

“For consumers with hypersensitivity to ranitidine ingredients, there is a reasonable possibility that ingestion of cetirizine tablets contaminated with ranitidine could lead to serious adverse events,” the FDA said.

Symptoms of anaphylaxis may include low blood pressure, difficulty breathing, difficulty swallowing, swelling of the throat or face, severe itching, constipation and loss of consciousness.

Unique Pharmaceuticals said it had not received any reports of adverse events associated with the recall.

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Some cetirizine hydrochloride tablets were found to have red spots or discoloration, prompting a nationwide recall. (US Food and Drug Administration / Fox News)

The issue was discovered after a pharmacy technician noticed a discrepancy while counting pills while dispensing them, according to regulators. Some pills appeared to have a “red dot,” while others appeared to be modified or have multiple red dots.

The recalled products are reported to be distributed across the country to wholesalers and retailers.

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A woman sneezes while working in her office. (iStock / Stock)

The affected antihistamine is packaged in a high density polyethylene (HDPE) bottle containing 100 tablets of 5 mg cetirizine hydrochloride tablet USP under National Drug Code (NDC) 16571-401-10.

Four production lots are included in the recall: GY825029, GY825030, GY825031 and GY825032.

All affected areas have an expiration date of October 2028.

Unique Pharmaceuticals notified its distributor, Rising Pharma Holdings Inc., of the recall.

Consumers with questions about the recall can contact Rising Pharma Holdings Inc. at 1-844-874-7464 from 8 am to 5 pm ET, Monday through Friday or email at [email protected].