GABAPENTIN Recall D-0312-2025
Description: Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.
GABAPENTIN Recall D-0312-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0312-2025 |
| Event ID | 96415 |
| Brand | GABAPENTIN |
| Generic Name | GABAPENTIN |
| Manufacturer | GABAPENTIN |
| Original Package? | 1 |
| Active Substance | GABAPENTIN |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 852 bottles |
| Recall Reason | Cross Contamination |
| Drug Classification | Class III |
| Drug Code Info | 20250416 |
| Product NDC | 62756-137 62756-138 62756-139 |
| Product NUI | N0000008486 |
| Drug UPC | 0362756204010 0362756202016 0362756138025 |
| Pharma Class (PE) | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| Recall Initiation Date | 20250304 |
| Report Date | 20250416 |
| Classification Date | 20250404 |
| Address | 2 Independence WayN/A Princeton, NJ 08540-6620 United States |
| Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 6CW7F3G59X |
| Drug Application Number | ANDA077242 |
| Structured Product Labeling (SPL ID) | 4ae9b022-cdbb-43d3-85f0-332f77c25d34 |
| Structured Product Labeling (SPL Set ID) | c9a05f0c-b5f0-422c-9d67-6d0efc921a74 |
| Similar To |