FDA-PR2026-07-18CHEMICAL

Unique Pharmaceutical Cetirizine 5 mg tablets recalled for ranitidine cross-contamination risk

UNDECLARED INGREDIENTSNationwide distributionDrugs

What this means

Four lots of Unique Pharmaceutical Cetirizine Hydrochloride 5 mg tablets were found to be cross-contaminated with ranitidine. The contamination was discovered when pharmacy staff noticed red discoloration on some tablets. People with sensitivity to ranitidine could experience serious allergic reactions.

  • Check your cetirizine bottle for lot numbers GY825029, GY825030, GY825031, or GY825032 (expiration 10/2028).
  • Stop taking the product if your lot matches and contact your pharmacy or doctor.
  • Return the recalled product to your pharmacy.
  • Call Rising Pharma Holdings at 1-844-874-7464 (8 a.m.–5 p.m. EST, Mon–Fri) with questions.

Product photos

Product Bottle: HDPE bottle of Cetirizine Hydrochloride Tablets USP 5 mg, 100 tablets.
Product Bottle: HDPE bottle of Cetirizine Hydrochloride Tablets USP 5 mg, 100 tablets.
Product Label: Label of Cetirizine Hydrochloride Tablets USP 5 mg, 100 tablets.
Product Label: Label of Cetirizine Hydrochloride Tablets USP 5 mg, 100 tablets.
Cetirizine Hydrochloride Tablets USP 5 mg (tablets): Cetirizine Hydrochloride Tablets USP 5 mg.
Cetirizine Hydrochloride Tablets USP 5 mg (tablets): Cetirizine Hydrochloride Tablets USP 5 mg.
The agency's original wording
Hazard

FOR IMMEDIATE RELEASE – July 18th, 2026 – Panoli, Gujarat, Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) is voluntarily recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg to the consumer level due to cross contamination with Ranitidine.

Intended for
All ages
Illnesses reported
None reported

Official notice

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unique-pharmaceutical-laboratories-div-j-b-chemicals-pharmaceuticals-ltd-issues-voluntary-nationwide

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