drugs HIGH RISK Updated 2026-07-29

JB Chemicals and Pharmaceuticals Ltd recalls Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle,

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Recalled Product

Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.

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Hazard / Issue

Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall