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
Bisoprolol Fumarate and Hydrochlorothiazide tablets (2.5 mg/6.25 mg) manufactured by Unichem Laboratoris Ltd. are being recalled nationwide because they contain higher levels of a nitrosamine impurity called N-Nitroso Bisoprolol than allowed. The affected product is a 100-count bottle with NDC 29300-187-01, distributed across all U.S. states and Puerto Rico. This is a Class I recall, the most serious classification.
- Recalling firm
- Unichem Pharmaceuticals USA Inc.
- 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.
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-01-21
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide and PR.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/fd25a308-1874-45b3-95d5-86e97825e31b