Recalls / Class II
Class IID-0507-2025
Product
Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, 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# M05205, Exp Date 10/2026
Why it was recalled
Defective container; blister packaging inadequately sealed.
Recalling firm
- Firm
- The Harvard Drug Group LLC
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 23,232 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2025-06-19
- FDA classified
- 2025-07-03
- Posted by FDA
- 2025-07-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0507-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.