Drug recall D-0301-2026
Product
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
Reason for recall
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Lots and codes
Lot # GBHL24005A, Exp Date: 09/2026
Recall details
- Recalling firm
- Unichem Pharmaceuticals USA Inc., East Brunswick, NJ
- Quantity
- N/A
- Distribution
- US Nationwide and PR.
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 21, 2026
Related products
- Bisoprolol fumarate and hydrochlorothiazide – drug information
- NDC 29300-189 Bisoprolol fumarate and hydrochlorothiazide · Hydrochlorothiazide 6.25 mg/1; Bisoprolol Fumarate 10 mg/1 · Unichem Pharmaceuticals (USA), Inc.
- NDC 29300-187 Bisoprolol fumarate and hydrochlorothiazide · Hydrochlorothiazide 6.25 mg/1; Bisoprolol Fumarate 2.5 mg/1 · Unichem Pharmaceuticals (USA), Inc.
- NDC 29300-188 Bisoprolol fumarate and hydrochlorothiazide · Hydrochlorothiazide 6.25 mg/1; Bisoprolol Fumarate 5 mg/1 · Unichem Pharmaceuticals (USA), Inc.