⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

SUN PHARMACEUTICAL INDUSTRIES INC: Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Dis

DrugsSource: FDA (drug) · Date: 2026-06-17

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
SUN PHARMACEUTICAL INDUSTRIES INC
Product
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.
Reason / 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
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the United States
Recall initiated
2026-05-29
Code info
Lot #: BAG0074A, Exp. Date: 1/31/2027.
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Princeton
State
NJ
Country
United States
Event id
99113
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