Reported Jul 30, 2025 · Ongoing
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured…
Cipla USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cipla USA, Inc. · 10 Independence Blvd · Warren, NJ · 07059-2730
Is this the product you have?
- Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only
- Manufactured byCipla Ltd. Indore SEZ, Pithampur, India
- Manufactured for
Ciple USAInc. 10 Independence BoulevardSuite 300WarrenNJ 07059. NDC# 69097-319-86 (pouch)69097-319-87 (carton)
- Lot codes and dates
Batch # 4IA0505Exp 09/31/2026
- Amount recalled
- 13,680 ampoules
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Cipla USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.