Gabapentin Capsules — Class II drug recall D-0031-2026
Ongoing recall by The Harvard Drug Group LLC, reported 2025-10-29, distributed nationwide. Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability
| Recall number | D-0031-2026 |
|---|---|
| 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 | 2025-10-10 |
| Classified | 2025-10-17 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00904-6665, 00904-6665-61, 00904-6666, 00904-6666-61, 00904-6667, 00904-6667-61, 55154-3363, 55154-3363-00, 55154-7992, 55154-7992-00, 55154-7993, 55154-7993-00 |
| Lot numbers | M04989, M04989A, M05056, M05056A, M05150, M05150A, M05312, M05312A, M05342, M05342A |
| Expiration dates | 2026-02, 2026-04, 2026-07, 2027-01 |
Product
Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).
Reason for recall
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
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-0031-2026. 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.