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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 numbera) Lot I1606609 and Lot I1606610 Exp. Date 05/2018; Lot I1610639 Exp. Date 09/2018 b) Lot #I1606610 Exp Date 05/2018; Lot I1607847 and Lot I1607845 Exp Date 06/2018; Lot I1610639 Exp Date 09/2018
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
NDC69097-878-03
Show the full FDA record
Full product labelbuPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) 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
Recalling firmInvaGen Pharmaceuticals, Inc.
DistributionNationwide
QuantityN/A
Recall initiated2018-03-15
Report date2018-04-11
Recall completed2021-09-15
Recall numberD-0619-2018
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.