Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Bupropion recalled?

Yes — there is an active recall. 3 ongoing FDA recalls mention Bupropion (44 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Bupropion. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Bupropion recalls on record

none so far in 2026; 44 on record, newest first
Class III · Low risk

buPROPion Hydrochloride Extended-¿release Tablets USP

Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.

Terminated Dissolution failure Sun Pharma Global Fze NDC 47335-738-86 D-1345-2015
Class II · Moderate risk

CONTRAVE (naltrexone HCl and bupropion HCl)

Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.

Terminated Failed specification Takeda Pharmaceuticals North America, Inc. NDC 64764-890-99 D-1206-2015
Class II · Moderate risk

Bupropion HCI active pharmaceutical ingredient packaged in…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-553-2015
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

buPROPion HCl ER

Labeling:Label Mixup; buPROPion HCl ER (XL), Tablet, 150 mg may be potentially mislabeled as MESALAMINE CR, Capsule, 250 mg, NDC 54092018981, Pedigree: AD52412_1, EXP: 5/17/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-722-2014
Class II · Moderate risk

buPROPion HCl ER Tablet

Labeling: Label Mixup; buPROPion HCl ER Tablet, 200 mg may be potentially mislabeled as AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002726, EXP: 6/6/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-573-2014