Recalls / Class II
Class IID-0030-2026
Product
Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61
- Brand name
- Gabapentin
- Generic name
- Gabapentin
- Active ingredient
- Gabapentin
- Route
- Oral
- NDCs
- 0904-6665, 0904-6666, 0904-6667
- FDA application
- ANDA090858
- Affected lot / code info
- Lot # M04950, Exp Date: 01/2026; Lot # M04989, M04990, Exp Date: 02/2026; Lot # M05056, Exp Date: 04/2026; Lot # M05150, Exp Date: 07/2026; Lot # M05290, Exp Date: 11/2026; Lot # M05312, M05342, Exp Date: 01/2027; Lot # M05369, M05386, Exp Date: 02/2027.
Why it was recalled
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Recalling firm
- Firm
- The Harvard Drug Group LLC
- Manufacturer
- Major Pharmaceuticals
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, Dublin, Ohio 43017-1091
Distribution
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-10-10
- FDA classified
- 2025-10-17
- Posted by FDA
- 2025-10-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0030-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.