FDA Lists Cetirizine Recall Over Possible Ranitidine Cross-Contamination
The FDA posted a nationwide recall on July 20, 2026, for four lots of cetirizine hydrochloride tablets USP 5 mg because of potential cross-contamination with ranitidine.
Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., announced the voluntary recall on July 18. The product was distributed nationwide by Rising Pharma Holdings through several wholesalers and retailers.
What is recalled
The recall covers 100-tablet HDPE bottles labeled cetirizine hydrochloride tablets USP 5 mg. The National Drug Code, or NDC, is 16571-401-10.
Consumers should check the lot number printed on the bottle. The affected lots are:
- GY825029
- GY825030
- GY825031
- GY825032
All four lots list an expiration date of October 2028. The recall does not automatically apply to every cetirizine product, strength, brand or lot. The product and lot details must match the FDA notice.
Why the tablets were recalled
The FDA-posted company announcement says a pharmacy technician noticed a discrepancy while counting tablets, including red dots and discoloration on some tablets. The notice cites potential cross-contamination with ranitidine.
The company’s risk statement, posted by FDA, says consumers with hypersensitivity to ranitidine could face serious hypersensitivity reactions, including anaphylaxis, if they ingested tablets contaminated with ranitidine. The notice describes a potential risk; it does not state that every tablet in the affected lots contains ranitidine.
As of the company’s July 18 announcement, Unique Pharmaceutical Laboratories said it had received no reports of adverse events related to the recall.
What consumers should do
If your bottle matches the recalled product, NDC and lot information, set it aside and contact a pharmacist or health-care provider for replacement guidance. FDA advises consumers to compare the lot number on their medicine with the lot number in the recall notice.
Do not assume that another bottle of cetirizine is affected unless its labeling matches the FDA notice. People who rely on cetirizine for ongoing allergy treatment should speak with a clinician or pharmacist about an appropriate replacement rather than stopping long-term treatment without medical advice.
Anyone with known ranitidine hypersensitivity who may have taken tablets from an affected lot should seek prompt medical advice. Seek emergency care for trouble breathing, swelling of the face or throat, fainting or rapidly worsening symptoms.
How to get help
Consumers can contact Rising Pharma Holdings at 1-844-874-7464 from 8 a.m. to 5 p.m. Eastern time, Monday through Friday, or by email at pv@risingpharma.com or qa@risingpharma.com.
Suspected adverse reactions and product-quality problems can be reported to the FDA’s MedWatch program. Consumers should also contact a physician or other health-care provider about problems they believe may be related to the product.
FDA’s drug-recall index lists the cetirizine recall dated July 20, 2026, without a terminated-recall designation. FDA says recalls without that designation are either ongoing or completed, so consumers should continue checking the agency’s recall information for updates.
Sources
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