Recalls / Class II
Class IID-0508-2025
Product
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0
- Brand name
- Gabapentin
- Generic name
- Gabapentin
- Active ingredient
- Gabapentin
- Route
- Oral
- NDCs
- 55154-3363, 55154-7992, 55154-7993
- FDA application
- ANDA090858
- Affected lot / code info
- Lot# M05205A and M05205B, Exp Date 10/2026.
Why it was recalled
Defective container; blister packaging inadequately sealed.
Recalling firm
- Firm
- The Harvard Drug Group LLC
- Manufacturer
- Cardinal Health 107, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 3,527 bags
- 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-0508-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.