Quick Facts at a Glance
- Recall Date
- May 29, 2026
- Hazard Level
- HIGH
- Brands
- BUDESONIDE, Sun Pharmaceutical Industries, Inc.
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- BUDESONIDE, Sun Pharmaceutical Industries, Inc.
- Model numbers
- Lot #: BAG0074A, Exp. Date: 1/31/2027.
- UPC codes
- 47335-631, 47335-632, 47335-633, 47335-631-48, 47335-631-49, 47335-632-48, 47335-632-49, 47335-633-48 +1 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 29, 2026
Reported by FDA DRUG
June 17, 2026
RecallRadar source check
June 23, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact SUN PHARMACEUTICAL INDUSTRIES INC or your healthcare provider for guidance. Notification method: Letter
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Full 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.. Generic: BUDESONIDE; Brand: BUDESONIDE. Reason: 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. Classification: Class II. Quantity: N/A. Distribution: Nationwide within the United States
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Safety Guide
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