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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 numberJKN5124A and JKN5229A, exp 10/2016
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 Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 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, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86
Recalling firmSun Pharmaceutical Industries, Inc.
DistributionNationwide
Quantity31,762 bottles
Recall initiated2016-09-13
Report date2016-10-12
Recall completed2018-07-02
Recall numberD-0007-2017
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.