Bisoprolol Fumarate and Hydrochlorothiazide Tablets 2.5 mg/6.25 mg
Unichem Pharmaceuticals recalls Bisoprolol/Hydrochlorothiazide 2.5/6.25 mg tablets (NDC 29300-187-01) due to N-Nitroso Bisoprolol impurity specification failure.
Do not use this medication. Contact your pharmacy or healthcare provider immediately for a replacement or alternative blood pressure medication. Return the recalled product to your pharmacy.
Why it was recalled
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
How to identify it
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
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Unichem Pharmaceuticals USA Inc.
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification