Unichem Pharmaceuticals USA Inc. recalls Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UN
Recalled February 11, 2026 · FDA recall D-0301-2026 · Unichem Pharmaceuticals USA
Hazard
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. · FDA Class II
Units
N/A
Sold at
US Nationwide and PR.
Description
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
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
Manufacturer(s)
Unichem Pharmaceuticals USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →