FDA Drug recall D-1067-2013
Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-coun…
- FDA Drug
- Class III
- terminated
- Published 2013-10-09
On 2013-10-09 the FDA classified a Class III recall of Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-coun… by Osmotica Pharmaceutical, citing failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1067-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-09-16 |
| Published | 2013-10-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Osmotica Pharmaceutical |
| Distribution | US |
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
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Identifiers
| code_info | Lot #: a) 58975, 58976, 58977, 65165 , Exp 01/14; b) 58973, 58974, 65131, Exp: 01/14 |
|---|
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-1067-2013%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.