Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Terminated Initiated Jan 4, 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 Dissolution Specifications; 8-hours for the 18-month 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 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217

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 Pharmaceuticals
NDC code
67767-142-30
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-175-2013 · 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 dissolution failure recalls from 2013

All dissolution failure recalls
Class II · Moderate risk

Pyridostigmine Bromide Tablets USP

Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.

Terminated Dissolution failure Corepharma LLC NDC 64720-128-10 D-1079-2014