Class III
Ongoing
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, 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 16571-402-10.
This recall is currently active, issued October 29, 2025. It was issued by Jb Chemicals And Pharmaceuticals Ltd.
- Recall Initiated
- September 12, 2025
- Posted
- October 29, 2025
- Recall Number
- D-0032-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9936 bottles
- Firm Location
- Mumbai, India
- Official Source
- View on FDA website ↗
Reason for Recall
Tablet/Capsules Imprinted with Wrong ID
Distribution
U.S. Nationwide
Lot / Code Info
Lot # PY925014A; Exp. 1/31/2028
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