The FDA announced a voluntary recall of select lots of generic cetirizine (5 mg, 100-count) after possible cross-contamination with ranitidine was detected. The manufacturer, Unique Pharmaceutical Laboratories, initiated the recall after pharmacy staff noticed red dots and discoloration on some tablets. The agency warned contaminated tablets could trigger serious adverse events — including anaphylaxis — in people allergic or hypersensitive to ranitidine. Affected lots (GY825029–GY825032) carry an October 2028 expiration and were distributed nationwide.
Popular Allergy Tablet Recalled After Possible Ranitidine Cross-Contamination — FDA Warns of 'Life-Threatening' Reactions
white bottle displaying Cetirizine Hydrochloride
Federal regulators have announced a voluntary recall of select lots of an over-the-counter cetirizine hydrochloride tablet (generic Zyrtec) after the manufacturer reported possible cross-contamination with ranitidine. The U.S. Food and Drug Administration (FDA) says the contamination could cause serious reactions, including anaphylaxis, in people sensitive to ranitidine.
Cetirizine hydrochloride has been recalled due to potential cross-contamination concerns.
What Was Recalled
Product: Cetirizine hydrochloride tablets USP, 5 mg (generic Zyrtec), 100-count HDPE bottle
NDC: 16571-401-10
Manufacturing Lots: GY825029, GY825030, GY825031, GY825032
Expiration Date: October 2028
Manufacturer/Initiator: Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., Panoli, Gujarat, India
Distributor Notified: Rising Pharma Holdings Inc.
Why the Recall Was Issued
The recall was initiated after a pharmacy technician observed tablets with a red dot or discoloration while dispensing. Subsequent investigation raised concern that some cetirizine tablets may be contaminated with ranitidine, a stomach-acid reducer previously withdrawn from the U.S. market in 2020 because of contamination with NDMA (a probable human carcinogen). A reformulated ranitidine product was later approved in 2025.
Certain cetirizine hydrochloride tablets were found with red dots or discoloration, prompting a nationwide recall.
"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 events," the FDA said.
Health Risks
The FDA warns that ingestion of contaminated tablets could cause serious adverse events in susceptible people. Most notably, anaphylaxis is possible — a rapid, severe allergic reaction that can include low blood pressure, difficulty breathing, trouble swallowing, throat or facial swelling, intense itching, hives, and loss of consciousness. Anyone experiencing these symptoms should seek emergency medical care immediately (call 911 or local emergency services).
A woman sneezes while working at her home office.
What Consumers Should Do
- Stop using the product immediately if you have the affected lots or notice red dots/discoloration on tablets.
- Check the bottle for NDC 16571-401-10 and the lot numbers listed above; if they match, do not consume the tablets.
- If you believe you have experienced an adverse reaction after taking the product, contact your healthcare provider right away and report the event to the FDA MedWatch program.
- For severe allergic symptoms, call 911 or seek emergency care without delay.
Producer Statement and Distribution
Unique Pharmaceutical Laboratories says it has not received any reports of adverse events tied to this recall so far. The recalled products were distributed nationwide to wholesalers and retailers in the United States.
How To Get More Information
Consumers with questions can contact Rising Pharma Holdings Inc. at 1-844-874-7464 (8 a.m. to 5 p.m. ET, Monday–Friday) or email [email protected]. You may also consult the FDA website for recall notices and guidance.
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