Bisoprolol Fumarate and Hydrochlorothiazide tablets recalled over manufacturing violations

Recall date

January 21, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Unichem Pharmaceuticals USA Inc. recalls Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: U…

Recall number

D-0301-2026

FDA classification

Class II

Brand / firm

Unichem Pharmaceuticals USA Inc.

Sold / distributed

US Nationwide and PR.

Why it was recalled

cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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