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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 numbera) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp. date 11/2019
Where it was soldProduct was distributed to one customer who may have further distributed the product.
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; 9-monthstability timepoint

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

Distributed by / forJubilant Cadista Pharmaceuticals, Inc.
NDC59746-
Show the full FDA record
Full product labelBuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD
Recalling firmJubilant Cadista Pharmaceuticals, Inc.
DistributionProduct was distributed to one customer who may have further distributed the product.
Quantitya) 3,072 bottles; b) 2,688 bottles
Recall initiated2019-02-28
Report date2019-03-13
Recall completed2020-03-05
Recall numberD-0519-2019
ClassificationClass III
FDA statusTerminated
Origin on fileSalisbury MD United States

Related

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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.