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) 300 mg Recalled by Actavis South Atlantic LLC Due to Failed USP Dissolution Test Requirements: Out-of-specification dissolution results...

Date: March 22, 2013
Company: Actavis South Atlantic LLC
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 South Atlantic LLC 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.

Quantity: 555,672 bottles

Why Was This Recalled?

Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Actavis South Atlantic LLC

Actavis South Atlantic LLC has 3 total recalls tracked by RecallDetector.

Related Recalls

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