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 (XL) Recalled by Actavis Inc Due to Failed Dissolution Specifications: Dissolution test results at 8...

Date: July 31, 2013
Company: Actavis 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 Actavis Inc directly.

Affected Products

BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.

Quantity: 15,132 bottles

Why Was This Recalled?

Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Actavis Inc

Actavis Inc has 17 total recalls tracked by RecallDetector.

Related Recalls

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