Could cause temporary or reversible harm; serious harm is unlikely.
CGMP Deviations
| Brand name | GABAPENTIN |
| Generic name | GABAPENTIN |
| Active ingredient(s) | GABAPENTIN |
| Distributed by / for | Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 |
| NDC | 68462-126-05 |
| Full product label | Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05. |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
| Distribution | U.S. Nationwide |
| Quantity | N/A |
| Recall initiated | 2025-03-13 |
| Report date | 2025-04-16 |
| Recall completed | — |
| Recall number | D-0320-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Mahwah NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗