Venlafaxine — Class III drug recall D-1067-2013
Terminated recall by Osmotica Pharmaceutical Corp, reported 2013-10-09, distributed nationwide. Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
| Recall number | D-1067-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Osmotica Pharmaceutical Corp, Marietta, GA, United States |
| Recall initiated | 2013-09-16 |
| Classified | 2013-09-27 |
| Reported by FDA | 2013-10-09 |
| Terminated | 2014-05-09 |
| Distributed | Nationwide (US) |
| Quantity | 57,857 bottles |
| Reason classes | specification failure |
| NDC | 00131-3268-32, 00131-3268-46 |
Product
Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC 28405, USA.
Reason for recall
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
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-1067-2013. 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.