FreshRecalls

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FDAClass II · Drug · Recalled June 17, 2026

Budesonide Inhalation Suspension recall — SUN PHARMACEUTICAL INDUSTRIES INC

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0607-2026
Brand
SUN PHARMACEUTICAL INDUSTRIES
Classification
Class II
Units affected
N/A
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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.

Affected products

Companies & origin

Recalling firm location
Princeton, NJ, United States
Firm address
2 Independence Way, N/A, 08540-6620

Identifying details (verbatim from the notice)

Product codes / lots
Lot #: BAG0074A, Exp. Date: 1/31/2027.
Distribution
Nationwide within the United States
Firm notified the public via
Letter
FDA event ID
99113
Recall initiated
May 29, 2026
FDA classified
June 18, 2026
FDA report date
June 17, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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