Unichem Pharmaceuticals USA Inc. recalls Bisoprolol Fumarate and Hydrochlorothiazide tablets
- Recalling company
- 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 II – may cause temporary or medically reversible health consequences
- Recall date
- Jan 21, 2026
- Reported
- Feb 11, 2026
- Distribution
- US Nationwide and PR.
- Status
- Ongoing
- Quantity
- N/A
- Lot / codes
- Lot # GBHL24005A, Exp Date: 09/2026
- Company location
- East Brunswick, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0301-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0301-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.