Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx On...
FDA Recall #D-0301-2026 — Class II — January 21, 2026
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
Reason for Recall
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Recalling Firm
Unichem Pharmaceuticals USA Inc. — East Brunswick, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
US Nationwide and PR.
Code Information
Lot # GBHL24005A, Exp Date: 09/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated