FDA Drug recall D-0311-2025
Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05
- FDA Drug
- Class III
- ongoing
- Published 2025-04-16
On 2025-04-16 the FDA classified a Class III recall of Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05 by Sun Pharmaceutical Industries, citing cross Contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0311-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-03-04 |
| Published | 2025-04-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Reason
Cross Contamination
Identifiers
| ndc | 62756-137-02 |
|---|---|
| ndc | 62756-137-03 |
| ndc | 62756-137-05 |
| ndc | 62756-137-04 |
| ndc | 62756-137-01 |
| ndc | 62756-138-02 |
| ndc | 62756-138-03 |
| ndc | 62756-138-05 |
| ndc | 62756-138-04 |
| ndc | 62756-138-01 |
| ndc | 62756-139-02 |
| ndc | 62756-139-03 |
| ndc | 62756-139-05 |
| ndc | 62756-139-04 |
| ndc | 62756-139-01 |
| ndc | 62756-202-01 |
| ndc | 62756-202-03 |
| ndc | 62756-204-01 |
| ndc | 62756-204-03 |
| code_info | Lot # a) HAD1458A, Exp. date 04/2025, HAD2718A, Exp. date 07/2025, b) HAD3432A, exp. date 08/2025 |
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-0311-2025%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.