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Class II · ModerateActive recall

Budesonide

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

Does this affect you?
Check your lot numberLot # 100047273; Exp. 07/2025
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

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 byActavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA
Brand nameBUDESONIDE
Generic nameBUDESONIDE
Active ingredient(s)BUDESONIDE
Distributed by / forActavis Pharma, Inc., Parsippany, NJ 07054 USA
NDC0591-2510-30
Show the full FDA record
Full product labelBudesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30
Recalling firmTeva Pharmaceuticals USA, Inc
DistributionNationwide
Quantity10,672 30-count bottles
Recall initiated2024-01-08
Report date2024-02-07
Recall completed—
Recall numberD-0275-2024
ClassificationClass II
FDA statusOngoing
Origin on fileParsippany 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.