Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Venlafaxine HCL ER Capsule USP Recalled by Zydus Pharmaceuticals USA Inc Due to Failed Dissolution Specifications: out of specification dissolution results...

Date: July 19, 2016
Company: Zydus Pharmaceuticals USA Inc
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 Zydus Pharmaceuticals USA Inc directly.

Affected Products

Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.

Quantity: 223,776 bottles

Why Was This Recalled?

Failed Dissolution Specifications: out of specification dissolution results in retained samples

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Zydus Pharmaceuticals USA Inc

Zydus Pharmaceuticals USA Inc has 41 total recalls tracked by RecallDetector.

Related Recalls

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