FDARecalled Feb 11, 2026 · #D-0301-2026
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, In...
Hazard
Class II — temporary health risk
Be the first to hear about future recalls.
Add the things you own to a watchlist. We’ll alert you the moment one matches.
Get started, freeDescription
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. Classification: Class II Distribution: US Nationwide and PR.
Product details
- 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
- Type
- Drugs
- Manufacturer
- Unichem Pharmaceuticals USA Inc.
- Model numbers
- GBHL24005A
- UPCs
- —