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Class III · Lower riskRecall completed

Bupropion

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: MR3365, Exp. Feb 17
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byCadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534 foreign manufacturer
Brand nameBUPROPION
Generic nameBUPROPION
Active ingredient(s)BUPROPION HYDROCHLORIDE
Distributed by / forZydus Pharmaceuticals USA inc. Pennington, NJ 08534
NDC68382-354-05
Show the full FDA record
Full product labelBuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05
Recalling firmZydus Pharmaceuticals USA Inc
DistributionNationwide
Quantity2,472 units
Recall initiated2016-08-03
Report date2016-11-30
Recall completed2018-07-12
Recall numberD-0149-2017
ClassificationClass III
FDA statusTerminated
Origin on filePennington NJ United States

Related

Bupropion recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.