Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Terminated Initiated Mar 29, 2012 (15 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: Possible 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), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10, carton barcode 6373944910.

Affected NDC 63739-0449-10

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

Drug: Bupropion Category: Mental Health Medication

Recalling firm
McKesson Packaging Services
NDC code
63739-449-10
Origin
NC, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-001-2013 · 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

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Other recalls by McKesson Packaging Services

All 2012 recalls
Class III · Low risk

Diltiazem CD

Failed Dissolution Specifications. High dissolution results were obtained during stability testing.

Terminated Dissolution failure Mckesson Packaging Services NDC 63739-284-10 D-0715-2018