Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets Recalled by Osmotica Pharmaceutical Corp Due to Failed Dissolution Specification:12 hour time point at 18...

Date: September 16, 2013
Company: Osmotica Pharmaceutical Corp
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Osmotica Pharmaceutical Corp directly.

Affected Products

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.

Quantity: 57857 bottles

Why Was This Recalled?

Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Osmotica Pharmaceutical Corp

Osmotica Pharmaceutical Corp has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report