Why it was recalled
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
Product description
Budesonide 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.
Lot numbers, UPCs & expiration codes
Lot #: BAG0074A, Exp. Date: 1/31/2027.
Where it was sold
Nationwide within the United States
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-0607-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 29, 2026
- FDA report date
- Jun 17, 2026
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0607-2026, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99113
- Address
- 2 Independence Way
- Code information
- Lot #: BAG0074A, Exp. Date: 1/31/2027.
- Postal code
- 08540-6620
- Report date
- Jun 17, 2026
- Product type
- Drugs
- Recall number
- D-0607-2026
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Reason for recall
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Budesonide 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 29, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 18, 2026