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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 numberLot #s: a) BU15001B, BU15003D, Exp 12/16; b) BU15002A, Exp 12/16
Where it was soldNationwide in the USA
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 Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

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 byJulibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA foreign manufacturer
Distributed by / forJubilant Cadista Pharmaceuticals, Inc.
NDC59746-315-60
Show the full FDA record
Full product labelBuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
Recalling firmJubilant Cadista Pharmaceuticals, Inc.
DistributionNationwide in the USA
Quantity20,882 bottles
Recall initiated2016-04-08
Report date2017-04-19
Recall completed2017-04-17
Recall numberD-0669-2017
ClassificationClass III
FDA statusTerminated
Origin on fileSalisbury MD 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.