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Class III · Lower riskRecall completed

Duloxetine

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

Does this affect you?
Check your lot numberLot #: G602051, Exp. 12/2017
Where it was soldNationwide within the United States
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 Specification

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 byLupin Limited Goa 403 722 India foreign manufacturer
Brand nameDULOXETINE
Generic nameDULOXETINE
Active ingredient(s)DULOXETINE HYDROCHLORIDE
Distributed by / forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States
NDC68180-295-06
Show the full FDA record
Full product labelDuloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068
Recalling firmLupin Pharmaceuticals Inc.
DistributionNationwide within the United States
Quantity111,648 units
Recall initiated2017-11-21
Report date2017-12-06
Recall completed2019-04-15
Recall numberD-0097-2018
ClassificationClass III
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

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.