Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts
Class III · Low risk Terminated Initiated Mar 22, 2013 (14 years ago)

buPROPion Hydrochloride Extended-Release Tablets

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

Cause type: Dissolution failure

The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.

What was recalled

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.

Affected NDC 67767-0142-30

Compare with the code on your package — it is the most precise check available.

Drug: Bupropion Category: Mental Health Medication

Recalling firm
Actavis South Atlantic LLC
NDC code
67767-142-30
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-248-2013 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Bupropion recalls

See all

Other recalls by Actavis South Atlantic LLC

All 2013 recalls
Class III · Low risk

buPROPion Hydrochloride Extended-Release Tablets

Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.

Terminated Dissolution failure Actavis South Atlantic LLC NDC 67767-142-30 D-917-2013
Class II · Moderate risk

Ranitidine Syrup

Failed Impurity/Degradation Specification; "Related Compound C"

Terminated Impurity / degradation Actavis South Atlantic LLC D-829-2013