Recalls / Class II
Class IID-0301-2026
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
- Brand name
- Bisoprolol Fumarate And Hydrochlorothiazide
- Generic name
- Bisoprolol Fumarate And Hydrochlorothiazide
- Active ingredients
- Bisoprolol Fumarate, Hydrochlorothiazide
- Route
- Oral
- NDCs
- 29300-187, 29300-188, 29300-189
- FDA application
- ANDA079106
- Affected lot / code info
- Lot # GBHL24005A, Exp Date: 09/2026
Why it was recalled
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Recalling firm
- Firm
- Unichem Pharmaceuticals USA Inc.
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Tower Center Blvd Ste 2200, N/A, East Brunswick, New Jersey 08816-1145
Distribution
- Quantity
- N/A
- Distribution pattern
- US Nationwide and PR.
Timeline
- Recall initiated
- 2026-01-21
- FDA classified
- 2026-01-30
- Posted by FDA
- 2026-02-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0301-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.