FDA Recall D-0222-2026
Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ
Class III Ongoing 177 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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.
Reason for recall
Cross Contamination with Other Products
Recall record
- Recall number
D-0222-2026- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S. Nationwide
- Recall initiated
- 2025-11-18
- Classified by FDA Center
- 2025-12-09
- FDA published
- 2025-12-17
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Firm location
- Mahwah, NJ
Drug identification
- Brand name(s)
- NEBIVOLOL
- Generic name(s)
- NEBIVOLOL HYDROCHLORIDE
- Manufacturer(s)
- AvKARE
- NDC(s)
42291-871, 42291-872, 42291-873, 42291-874- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.