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Class III · Lower riskRecall completed

Bupropion Hydrochloride

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

Does this affect you?
Check your lot numberLots: 524099M, 524100A, 521687A
Where it was soldNationwide and Puerto Rico
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: Failed stability testing for dissolution test at 18 months.

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 byActavis Pharma, Inc.
Brand nameBUPROPION HYDROCHLORIDE
Generic nameBUPROPION HYDROCHLORIDE
Active ingredient(s)BUPROPION HYDROCHLORIDE
Distributed by / forActavis Inc
NDC0591-3331-30
Show the full FDA record
Full product labelBuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
Recalling firmActavis Inc
DistributionNationwide and Puerto Rico
Quantity139,944 bottles
Recall initiated2013-11-15
Report date2014-02-05
Recall completed2015-06-16
Recall numberD-1043-2014
ClassificationClass III
FDA statusTerminated
Origin on fileParsippany 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.