Class IIOngoing

Budesonide Inhalation Suspension recall

FDA recall D-0607-2026 · initiated May 29, 2026

May cause temporary or medically reversible harm; low probability of serious harm.

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

Details

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.
Recalling company: Sun Pharm Industries
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide within the United States
Initiated: May 29, 2026
FDA report date: Jun 17, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0607-2026 ↗

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