JB Chemicals and Pharmaceuticals Ltd recalls Cetirizine Hydrochloride Tablets USP 5 mg
- Recalling company
- JB Chemicals and Pharmaceuticals Ltd
- 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.
- Reason
- 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.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Jun 24, 2026
- Reported
- Jul 29, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 34,020 100-count bottles.
- Lot / codes
- Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
- Company location
- Mumbai, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0732-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0732-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.