Gabapentin Capsules — Class II drug recall D-0508-2025
Ongoing recall by The Harvard Drug Group LLC, reported 2025-07-09, distributed nationwide. Defective container; blister packaging inadequately sealed.
| Recall number | D-0508-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group LLC, Dublin, OH, United States |
| Recall initiated | 2025-06-19 |
| Classified | 2025-07-03 |
| Reported by FDA | 2025-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 3,527 bags |
| Reason classes | packaging |
| NDC | 55154-3363, 55154-3363-00, 55154-7992, 55154-7992-00, 55154-7993, 55154-7993-00 |
| Lot numbers | M05205A, M05205B |
| Expiration dates | 2026-10 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0508-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.