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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 #: BAG0074A, Exp. Date: 1/31/2027.
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

Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution

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 bySun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India foreign manufacturer
Brand nameBUDESONIDE
Generic nameBUDESONIDE
Active ingredient(s)BUDESONIDE
Distributed by / forSun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
NDC47335-633-49
Show the full FDA record
Full product labelBudesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49.
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide within the United States
QuantityN/A
Recall initiated2026-05-29
Report date2026-06-17
Recall completed—
Recall numberD-0607-2026
ClassificationClass II
FDA statusOngoing
Origin on filePrinceton 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.