Unichem Pharmaceuticals USA Inc.

Drugs recall · D-0301-2026

Reason for recall

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

Product description

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

Recalling firm

Unichem Pharmaceuticals USA Inc.

Product quantity

N/A

Lot / code info

Lot # GBHL24005A, Exp Date: 09/2026

Distribution

US Nationwide and PR.

Recall initiated

2026-01-21

Status

Ongoing

Location

East Brunswick, NJ, United States

Voluntary / mandated

Voluntary: Firm initiated

Initial notification

Letter

Data from official federal safety records. Updated periodically. Verify on FDA.gov