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Class III · Lower riskRecall completed

Bupropion Hydrochloride (Sr)

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot# I1606579 and Lot# I1606580 Exp: 05/2018; Lot# I1612114 and Lot# I1612115 Exp: 11/2018
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; 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 byInvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 ---
Brand nameBUPROPION HYDROCHLORIDE (SR)
Generic nameBUPROPION HYDROCHLORIDE
Active ingredient(s)BUPROPION HYDROCHLORIDE
Distributed by / forCipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323
NDC69097-877-03
Show the full FDA record
Full product labelbuPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03
Recalling firmInvaGen Pharmaceuticals, Inc.
DistributionNationwide
QuantityN/A
Recall initiated2018-03-15
Report date2018-04-11
Recall completed2021-09-15
Recall numberD-0618-2018
ClassificationClass III
FDA statusTerminated
Origin on fileHauppauge NY 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.