Recalls / Class III
Class IIID-0222-2026
Product
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.
- Brand name
- Nebivolol
- Generic name
- Nebivolol Hydrochloride
- Active ingredient
- Nebivolol Hydrochloride
- Route
- Oral
- NDCs
- 42291-871, 42291-872, 42291-873, 42291-874
- FDA application
- ANDA203821
- Affected lot / code info
- Lot# 17240988; Exp. 05/31/2026
Why it was recalled
Cross Contamination with Other Products
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Manufacturer
- AvKARE
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 672 90-count bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-11-18
- FDA classified
- 2025-12-09
- Posted by FDA
- 2025-12-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0222-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.