Drug

Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LT

Recall date: 2026-02-11 · Source: FDA_DRUG

Brand / Firm

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.

Units affected

N/A

Description

View official recall notice →