Levetiracetam — Class II drug recall D-0386-2015
Terminated recall by Sun Pharma Global Fze, reported 2015-02-18, distributed nationwide. Failed Dissolution Specifications: 6 month time point.
| Recall number | D-0386-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharma Global Fze, Sharm, N/A, United Arab Emirates |
| Recall initiated | 2015-01-21 |
| Classified | 2015-02-12 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2015-10-23 |
| Distributed | Nationwide (US) |
| Quantity | 3,263 bottles |
| Reason classes | specification failure |
| NDC | 47335-0576-86 |
| Lot numbers | JKN0249A |
| Expiration dates | 2016-02 |
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 for recall
Failed Dissolution Specifications: 6 month time point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0386-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.