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Class III · Lower riskRecall completed

Carvedilol

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

Does this affect you?
Check your lot numberBatch QG0619030-A, exp 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

Failed Impurities/Degradation 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 byMade in India foreign manufacturer
Brand nameCARVEDILOL
Generic nameCARVEDILOL
Active ingredient(s)CARVEDILOL
Distributed by / forAurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520
NDC65862-143-05
Show the full FDA record
Full product labelCarvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05
Recalling firmAurobindo Pharma USA Inc.
DistributionNationwide in the US
Quantity7296 containers
Recall initiated2021-11-15
Report date2021-12-01
Recall completed2023-08-23
Recall numberD-0263-2022
ClassificationClass III
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.