The FDA on July 20 announced a voluntary recall of Cetirizine Hydrochloride Tablets USP 5 mg (generic Zyrtec) made by Unique Pharmaceutical Laboratories and distributed by Rising Pharma due to possible cross-contamination with ranitidine. A pharmacy technician found unexpected red dots and discoloration on some tablets; no consumer adverse events have been reported so far. Affected 100-count HDPE bottles carry lot numbers GY825029–GY825032 and expire October 2028. Do not use these bottles; contact your doctor for guidance and report any reactions to FDA MedWatch.
FDA Warns: Generic Zyrtec (Cetirizine 5 mg) Recalled for Possible Ranitidine Contamination — Check Lot Numbers Now
What You Need to Know About the Allergy Med Recallfotostorm - Getty Images
The U.S. Food and Drug Administration on July 20 announced a voluntary nationwide recall of Cetirizine Hydrochloride Tablets USP 5 mg (a generic form of Zyrtec) manufactured by Unique Pharmaceutical Laboratories and distributed by Rising Pharma Holdings Inc. Consumers should check their medicine cabinets for affected bottles and stop using the product immediately.
Why the recall? The recall was initiated after some tablets were potentially cross-contaminated with ranitidine, an older heartburn medication sold under brand names such as Zantac and Tritec. A pharmacy technician discovered the issue when they noticed unexpected red dots and discoloration on certain tablets during pill counting.
Health risk: To date, the FDA reports no consumer adverse events tied to the affected lots. However, people with hypersensitivity or allergy to ranitidine could experience severe reactions if exposed. Reported possible symptoms include anaphylaxis and signs such as low blood pressure (hypotension), difficulty breathing (dyspnea), trouble swallowing, throat or facial swelling, widespread itching (pruritus), hives (urticaria), and fainting—any of which can be life-threatening.
Expert note: "The timing and severity of adverse effects vary by age, dose, individual sensitivity and baseline liver or kidney function," says Irakli Todua, MD, an internal medicine physician at Tufts Medical Center. "Early signs—such as abdominal pain or dry mouth—may appear within 1–2 hours, while cardiovascular or sedative effects (low blood pressure, altered heart rate, drowsiness or agitation) may be delayed by several hours. There are no at-home antidotes. Call your doctor or 911 immediately if you suspect a severe reaction."
Affected products and lot numbers
- Product: Cetirizine Hydrochloride Tablets USP 5 mg (generic Zyrtec)
- Packaging: 100-count HDPE bottles
- Affected Lot Numbers: GY825029, GY825030, GY825031, GY825032
- Expiration Date on All Affected Bottles: October 2028
What to do if you have the product
- Do not take the medication from any bottle with an affected lot number.
- If you have already taken tablets from an affected bottle, contact your physician for guidance—even if you feel well—so a clinician can advise on monitoring or evaluation.
- If you experience signs of a severe allergic reaction, seek emergency care immediately (call 911 in the U.S.).
- Keep the bottle and lot number available for return or inspection; Rising Pharma is arranging returns of affected bottles.
Contact information
- Rising Pharma Holdings: 1-844-874-7464 (Monday–Friday, 8:00 AM–5:00 PM EST)
- Email: [email protected] or [email protected]
- FDA MedWatch: The FDA asks consumers to report any adverse reactions to its MedWatch Adverse Event Reporting program online or by mail/fax.
If you are unsure whether your bottle is affected, check the lot number and expiration date before taking any tablets. When in doubt, consult your pharmacist or healthcare provider for next steps.
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