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Class III · Lower riskRecall completed

buPROPion Hydrochloride Extended-release Tablets

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

Does this affect you?
Check your lot numberJKP0905A 04/17
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; 18 month stability 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 bySun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India foreign manufacturer
Distributed by / forSun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
NDC47335-0738-86
Show the full FDA record
Full product labelbuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86
Recalling firmSun Pharmaceutical Industries, Inc.
DistributionNationwide
Quantity11,618 bottles
Recall initiated2016-12-20
Report date2017-02-01
Recall completed2018-07-11
Recall numberD-0446-2017
ClassificationClass III
FDA statusTerminated
Origin on fileCranbury 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.