Recalls / Class III
Class IIID-0199-2026
Product
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
- Brand name
- Bisoprolol Fumarate And Hydrochlorothiazide
- Generic name
- Bisoprolol Fumarate And Hydrochlorothiazide
- Active ingredients
- Bisoprolol Fumarate, Hydrochlorothiazide
- Route
- Oral
- NDCs
- 68462-878, 68462-879, 68462-880
- FDA application
- ANDA215995
- Affected lot / code info
- Lot #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (c): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026
Why it was recalled
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Manufacturer
- GLENMARK PHARMACEUTICALS INC., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 619 River Dr, Elmwood Park, New Jersey 07407-1317
Distribution
- Quantity
- 11,136 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-11-21
- FDA classified
- 2025-12-01
- Posted by FDA
- 2025-12-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0199-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.