FDA Drug recall D-0312-2025
Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05
- FDA Drug
- Class III
- ongoing
- Published 2025-04-16
On 2025-04-16 the FDA classified a Class III recall of Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05 by Sun Pharmaceutical Industries, citing cross Contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0312-2025 |
| 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 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.
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) HAD1712B, Exp. date 03/2025 b) HAD1712C, exp. date 03/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class III · 2026-10-14 · Sun Pharmaceutical Industries - Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 262…
FDA Drug · Class II · 2026-08-26 · Sun Pharmaceutical Industries - Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswic…
FDA Drug · Class III · 2026-07-08 · Sun Pharmaceutical Industries
All Sun Pharmaceutical Industries recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0312-2025%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.