Venlafaxine Hydrochloride Extended-Release Tablets — Class II drug recall D-0236-2015
Terminated recall by Sun Pharma Global Inc., reported 2014-11-12, distributed nationwide. Failed Dissolution Specifications; 12 month stability time point
| Recall number | D-0236-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharma Global Inc., Dubai, N/A, United Arab Emirates |
| Recall initiated | 2014-09-26 |
| Classified | 2014-11-04 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2015-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 68,194 |
| Reason classes | specification failure |
| Lot numbers | JKM3855A, JKM3855B, JKM7265A, JKM7265B |
| Expiration dates | 2015-05-31, 2015-11-30 |
Product
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India
Reason for recall
Failed Dissolution Specifications; 12 month stability 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-0236-2015. 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.