# FDA recall D-1067-2013

> **Osmotica Pharmaceutical Corp** · Class III · drug recall initiated 2013-09-16.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1067-2013
- **Recalling firm:** Osmotica Pharmaceutical Corp
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-09-16
- **Report date:** 2013-10-09
- **Termination date:** 2014-05-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marietta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1067-2013

## Citation

> AI Analytics. FDA recall D-1067-2013. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1067-2013. Source: US FDA. Licensed CC0.

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