Class III โ€” Low Risk

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

BuPROPion Hydrochloride Extended-Release Tablets Recalled by Zydus Pharmaceuticals USA Inc Due to Failed Dissolution Specifications: Product did not meet dissolution...

Date: August 3, 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

BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05

Quantity: 2,472 units

Why Was This Recalled?

Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.

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