Class II
Ongoing
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
This recall is currently active, issued February 11, 2026. It was issued by Unichem Pharmaceuticals Usa Inc..
- Company
- Unichem Pharmaceuticals Usa Inc.
- Recall Initiated
- January 21, 2026
- Posted
- February 11, 2026
- Recall Number
- D-0301-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- East Brunswick, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Distribution
US Nationwide and PR.
Lot / Code Info
Lot # GBHL24005A, Exp Date: 09/2026
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