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Class II · ModerateRecall completed

Carvedilol

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

Does this affect you?
Check your lot numberZ006279, exp 12/31/2022
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

Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle

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 byCadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853 foreign manufacturer
Brand nameCARVEDILOL
Generic nameCARVEDILOL
Active ingredient(s)CARVEDILOL
Distributed by / forZydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853
NDC68382-095-05
Show the full FDA record
Full product labelCarvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05
Recalling firmZydus Pharmaceuticals (USA) Inc
DistributionNationwide in the US
Quantity2880 bottles
Recall initiated2021-08-13
Report date2021-08-25
Recall completed2023-04-03
Recall numberD-0753-2021
ClassificationClass II
FDA statusTerminated
Origin on filePennington NJ United States

Related

Recent 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.