Four lots of Cetirizine Hydrochloride Tablets USP 5 mg distributed across the United States are being recalled because they may have been cross-contaminated with ranitidine, a separate medicine used to reduce stomach acid.
Unique Pharmaceutical Laboratories announced the voluntary consumer-level recall on July 18, 2026. The U.S. Food and Drug Administration published the company announcement on July 20. Rising Pharma Holdings Inc. distributed the affected tablets nationwide through wholesalers and retailers.
Cetirizine is an antihistamine used to relieve allergy symptoms such as sneezing, a runny nose, itchy or watery eyes and hives. It is commonly sold as a generic alternative to Zyrtec.
Recalled cetirizine lots and bottle details
The recall applies to 5 mg cetirizine hydrochloride tablets packaged in 100-count high-density polyethylene bottles. Consumers should check the bottle for NDC 16571-401-10, an expiration date of October 2028 and one of these lot numbers:
- GY825029
- GY825030
- GY825031
- GY825032
The label identifies Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd. in Panoli, Gujarat, India, as the manufacturer and Rising Pharma Holdings Inc. as the distributor. The announcement does not specify how many bottles are being recalled.
How the possible contamination was discovered
A pharmacy technician noticed a discrepancy while counting the tablets for dispensing. Some pills reportedly had a red dot, while others appeared discolored or showed multiple red-colored spots. The complaint prompted an investigation that identified possible cross-contamination with ranitidine.
This type of recall requires consumers to check the precise NDC, lot number and expiration date instead of relying only on the medicine’s name. Accurate bottle identification was similarly important in a recent nationwide blood pressure medication recall affecting nearly 16,000 bottles.
What health risk does the recall involve?
Ranitidine was previously sold under the Zantac brand for heartburn, acid indigestion and other acid-related conditions. Older ranitidine products were removed from the U.S. market in 2020 over concerns involving NDMA, a probable human carcinogen. A reformulated ranitidine tablet was approved in 2025.
The immediate concern in this recall is the risk to people who are hypersensitive to ingredients in ranitidine. Accidentally taking contaminated cetirizine could cause severe hypersensitivity or anaphylaxis.
Possible symptoms include low blood pressure, difficulty breathing or swallowing, swelling of the throat or face, widespread itching, hives and loss of consciousness. These reactions can be life-threatening and require urgent medical attention.
Unique Pharmaceutical Laboratories said it had received no reports of adverse events associated with the recalled tablets when the announcement was issued.
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What should consumers do?
Consumers should compare the information on their bottle with all three recall identifiers: NDC, lot number and expiration date. A tablet that appears normal may still belong to an affected lot, so appearance alone should not be used to determine whether a product is covered.
Rising Pharma has notified distributors and direct customers by email and is arranging returns. Anyone with an affected bottle should contact the dispensing pharmacy or Rising Pharma for return instructions. People who still require allergy treatment should ask a pharmacist or healthcare provider about a suitable replacement.
Consumers reviewing medicines at home may also want to check the identifying information from the separate recall involving more than 2.5 million eye-drop bottles.
Anyone who develops breathing difficulty, throat or facial swelling, fainting or another severe reaction should seek emergency medical help. Other problems that may be connected with the tablets should be discussed with a physician or healthcare provider.
Contact details and FDA reporting
Consumers can call Rising Pharma Holdings Inc. at 1-844-874-7464 between 8 a.m. and 5 p.m. ET, Monday through Friday. Questions can also be sent to pv@risingpharma.com or qa@risingpharma.com.
Adverse reactions and product-quality problems can be reported to the FDA’s MedWatch program online or by calling 1-800-332-1088. Product photographs, the complete recall table and future updates are available in the official FDA recall announcement.
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