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Class II · ModerateRecall completed

Pioglitazone

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

Does this affect you?
Check your lot numberBatch # PF4520028B & PF4520028A, Exp. Date 11/2022
Where it was soldNationwide in the US
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

Superpotent and Failed Tablet/Capsule Specifications

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 byRising Pharma Holdings, Inc.
Brand namePIOGLITAZONE
Generic namePIOGLITAZONE
Active ingredient(s)PIOGLITAZONE HYDROCHLORIDE
Distributed by / forAurobindo Pharma USA, Inc., East Windsor, NJ --
NDC57237-221-05
Show the full FDA record
Full product labelPioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
Recalling firmAurobindo Pharma USA Inc.
DistributionNationwide in the US
Quantity792 bottles
Recall initiated2021-12-29
Report date2022-02-02
Recall completed2023-12-04
Recall numberD-0450-2022
ClassificationClass II
FDA statusTerminated
Origin on fileEast Windsor NJ 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.