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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 numberLot JKN3477A, exp 07/2016
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

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
Brand nameBUPROPION HYDROCHLORIDE
Generic nameBUPROPION HYDROCHLORIDE
Active ingredient(s)BUPROPION HYDROCHLORIDE
Distributed by / forSun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
NDC47335-737-86
Show the full FDA record
Full product labelbuPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86
Recalling firmSun Pharmaceutical Industries, Inc.
DistributionNationwide
Quantity16,085 bottles
Recall initiated2016-06-27
Report date2016-07-27
Recall completed2018-03-27
Recall numberD-1446-2016
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.