FDA Drug recall D-0507-2025
Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS,…
- FDA Drug
- Class II
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class II recall of Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS,… by The Harvard Drug Group, citing defective container; blister packaging inadequately sealed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0507-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-19 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | US |
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
Reason
Defective container; blister packaging inadequately sealed.
Identifiers
| ndc | 0904-6665-61 |
|---|---|
| ndc | 0904-6666-61 |
| ndc | 0904-6667-61 |
| code_info | Lot# M05205, Exp Date 10/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0507-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.