Budesonide Inhalation Suspension recall
SUN PHARMACEUTICAL INDUSTRIES INC recalled Budesonide Inhalation Suspension on June 17, 2026 because of 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. It was sold nationwide.
Why it was recalled
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's recalled
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.
Quantity: N/A
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Nationwide within the United States - Status
- Ongoing
- Recall number
- D-0607-2026
- Source
- U.S. Food and Drug Administration
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