Sun Pharmaceutical Budesonide Suspension Recall
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Dis
Updated May 29, 2026
Budesonide Inhalation Suspension 1mg/2mL single-dose ampules are being recalled because black or brown specks and particles have been found in the solution. Inhaling foreign particles could irritate the lungs and compromise the medication's effectiveness.
Is the SUN PHARMACEUTICAL INDUSTRIES INC recalled? Yes. This product was recalled by FDA on May 29, 2026. Details below.
What is recalled
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 single-dose ampules per pouch, 6 pouches per carton). NDC number: 47335-633-49. Manufactured by Sun Pharmaceutical Industries Limited (Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India) and distributed by Sun Pharmaceutical Industries, Inc. (Cranbury, NJ 08512).
Am I affected
You're affected if you have Budesonide Inhalation Suspension 1mg/2mL with NDC 47335-633-49. Check your ampule or carton for this NDC number and inspect the liquid inside for any black or brown specks or particles.
What to do right now
Stop using this product immediately. Do not use any ampules from affected cartons. Contact Sun Pharmaceutical Industries, Inc. or your pharmacy for instructions on how to return the medication and obtain a replacement.
The hazard
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
Brands affected
- Source
- FDA
- Category
- Drugs & Medications
- Recall ID
- fda-D-0607-2026
- Classification
- Class II
- Recalled
- May 29, 2026
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