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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 numberBatch # 4IA0505, Exp 09/31/2026
Where it was soldDistributed Nationwide in the USA
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

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

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 byCipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059 foreign manufacturer
Brand nameBUDESONIDE
Generic nameBUDESONIDE
Active ingredient(s)BUDESONIDE
Distributed by / forCiple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059
NDC69097-319-86
Show the full FDA record
Full product labelBudesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)
Recalling firmCipla USA, Inc.
DistributionDistributed Nationwide in the USA
Quantity13,680 ampoules
Recall initiated2025-06-30
Report date2025-07-30
Recall completed—
Recall numberD-0541-2025
ClassificationClass II
FDA statusOngoing
Origin on fileWarren 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.