FDA Recall D-0508-2025
The Harvard Drug Group LLC · Dublin, OH
Class II Ongoing 329 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Defective container; blister packaging inadequately sealed.
Recall record
- Recall number
D-0508-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2025-06-19
- Classified by FDA Center
- 2025-07-03
- FDA published
- 2025-07-09
- Recalling firm
- The Harvard Drug Group LLC
- Firm location
- Dublin, OH
Drug identification
- Brand name(s)
- GABAPENTIN
- Generic name(s)
- GABAPENTIN
- Manufacturer(s)
- Cardinal Health 107, LLC
- NDC(s)
55154-3363, 55154-7992, 55154-7993- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.