Recall: D-0301-2026

Class II - Potentially Harmful

Class IIClassification

2026-01-21Initiated

OngoingStatus

Unichem Pharmaceuticals USA InFirm

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

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

Distribution

US Nationwide and PR.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.