Venlafaxine Hydrochloride Extended-Release Tablets — Class II drug recall D-1283-2014
Terminated recall by Caraco Pharmaceutical Laboratories, Ltd., reported 2014-05-07, distributed nationwide. Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissoluti
| Recall number | D-1283-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI, United States |
| Recall initiated | 2014-03-20 |
| Classified | 2014-04-29 |
| Reported by FDA | 2014-05-07 |
| Terminated | 2015-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 160,105 bottles |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00341616758818, 00341616758832 |
| NDC | 41616-0758-81, 41616-0758-83 |
Product
Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Reason for recall
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
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-1283-2014. 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.