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Budesonide Inhalation Suspension
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DRUG RECALLMODERATE

Budesonide Inhalation Suspension

Sun Pharmaceutical is recalling Budesonide Inhalation Suspension (1mg/2mL) due to the presence of foreign black or brown particles.

What to do

Examine your medication for any visible particles or discoloration. If found, do not use the product and contact your healthcare provider or pharmacist for a replacement or further instructions.

Recalled
Listed
Updated
Recall No.
D-0607-2026
Agency
FDA
Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Recall ID
99113
Status
ONGOING

Why it was recalled

Sun Pharmaceutical is recalling Budesonide Inhalation Suspension due to the presence of foreign black or brown particulate matter within the ampoule solution. This recall affects the 1mg/2mL strength, packaged as 30 x 2 mL sterile single-dose ampules.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Budesonide Inhalation Suspension

Lot code
BAG0074A, 2027
Strength
1 mg
NDC / UPC
NDC 47335-633-49

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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Editorial summary by Recall Canary · summary updated 2026-06-19 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification