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Drug FDA Class II Ongoing Foreign material

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-2893

SUN PHARMACEUTICAL INDUSTRIES INC Published Jun 17, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact SUN PHARMACEUTICAL INDUSTRIES INC or your place of purchase with questions, and see the source record below for full details.
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

Hazards

Black/Brown Particulate Matter · primary

Affected products (1)

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.

BUDESONIDE · N/A

NDC: 47335-631, 47335-632, 47335-633, 47335-631-48, 47335-631-49, 47335-632-48, 47335-632-49, 47335-633-48, 47335-633-49
Code info: Lot #: BAG0074A, Exp. Date: 1/31/2027.

Affected areas

Nationwide

Timeline

  1. Initiated
    May 29, 2026
  2. Published
    Jun 17, 2026
Recall number
D-0607-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.