GABAPENTIN Recall D-0320-2025
Description: 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.
GABAPENTIN Recall D-0320-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0320-2025 |
| Event ID | 96474 |
| Brand | GABAPENTIN |
| Generic Name | GABAPENTIN |
| Manufacturer | GABAPENTIN |
| Original Package? | 1 |
| Active Substance | GABAPENTIN |
| Drug Route | ORAL |
| Distribution | U.S. Nationwide |
| Quantity | N/A |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20250416 |
| Product NDC | 68462-126 68462-127 |
| Product NUI | N0000008486 |
| Drug UPC | 0368462126011 0368462127018 |
| Pharma Class (PE) | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| Recall Initiation Date | 20250313 |
| Report Date | 20250416 |
| Classification Date | 20250408 |
| Address | 750 Corporate DrN/A Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 6CW7F3G59X |
| Drug Application Number | ANDA077662 |
| Structured Product Labeling (SPL ID) | e9df5772-56eb-4863-9fd3-3f7e304fad41 |
| Structured Product Labeling (SPL Set ID) | 3865a6e3-112c-490c-82ac-35401336b16e |
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