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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 numberL200791
Where it was soldFL, GA, SC
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

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

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 byHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Brand nameBUPROPION HYDROCHLORIDE
Generic nameBUPROPION HYDROCHLORIDE
Active ingredient(s)BUPROPION HYDROCHLORIDE
Distributed by / forHeritage Pharmaceuticals Inc. Eatontown, NJ 07724
NDC23155-191-01
Show the full FDA record
Full product labelbupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724
Recalling firmCardinal Health Inc.
DistributionFL, GA, SC
Quantity32 bottles
Recall initiated2021-03-15
Report date2021-06-02
Recall completed2024-06-17
Recall numberD-0489-2021
ClassificationClass II
FDA statusTerminated
Origin on fileDublin OH 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.