Why it was recalled
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Product description
Budesonide 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)
Lot numbers, UPCs & expiration codes
Batch # 4IA0505, Exp 09/31/2026
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0541-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 30, 2025
- FDA report date
- Jul 30, 2025
- Quantity
- 13,680 ampoules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cipla USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0541-2025, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97170
- Address
- 10 Independence Blvd
- Code information
- Batch # 4IA0505, Exp 09/31/2026
- Postal code
- 07059-2730
- Report date
- Jul 30, 2025
- Product type
- Drugs
- Recall number
- D-0541-2025
- Classification
- Class II
- Recalling firm
- Cipla USA, Inc.
- Product quantity
- 13,680 ampoules
- Reason for recall
- Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Budesonide 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)
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jun 30, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 22, 2025