FDA Drug recall D-0386-2015
Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind
- FDA Drug
- Class II
- terminated
- Published 2015-02-18
On 2015-02-18 the FDA classified a Class II recall of Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind by Sun Pharma Global Fze, citing failed Dissolution Specifications: 6 month time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0386-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-21 |
| Published | 2015-02-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sun Pharma Global Fze |
| Distribution | US |
Product
Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86
Reason
Failed Dissolution Specifications: 6 month time point.
Identifiers
| code_info | Lot #: JKN0249A Exp 02/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0386-2015%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.