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Class II · ModerateRecall completed

Bupropion Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots: HAC2240A, Exp 05/2023; HAC3162A, Exp 07/2023
Where it was soldNationwide in the U.S.A
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; during stability testing

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 Industries Limited, Gujrat, India foreign manufacturer
Brand nameBUPROPION HYDROCHLORIDE
Generic nameBUPROPION HYDROCHLORIDE
Active ingredient(s)BUPROPION HYDROCHLORIDE
Distributed by / forSun Pharmaceutical Industries, Inc., Cranbury, NJ
NDC47335-737-86
Show the full FDA record
Full product labelbuPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide in the U.S.A
Quantity5,344 Bottles
Recall initiated2023-05-09
Report date2023-05-31
Recall completed2024-02-27
Recall numberD-0761-2023
ClassificationClass II
FDA statusTerminated
Origin on filePrinceton 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.