FDA recall, , Moderate risk
Sun Pharmaceutical Industries Budesonide Inhalation Suspension
Budesonide Inhalation Suspension contains black or brown specs and particles in the solution.
Summary by Recall Canary from the FDA notice
What happened
Sun Pharmaceutical Industries Inc. recalled Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules, after a product quality complaint reported black/brown specs and particles within the ampoule solution. The recall began May 29, 2026, and was added to the FDA's Enforcement Report on June 8, 2026. The product was distributed nationwide within the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 47335-633-49
- Lot code
- BAG0074A
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- SUN PHARMACEUTICAL INDUSTRIES INCPrinceton, New Jersey
- Hazard
- Foreign object
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99113
- Recall number
- D-0607-2026
All recalls from SUN PHARMACEUTICAL INDUSTRIES INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
