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Budesonide

FDA recalls

4 rows

DateCompany and reasonClass
May 28, 2026Sun Pharmaceutical Industries Inc
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 · Ongoing
Jun 29, 2025Cipla USA, Inc.
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.		Class II · Ongoing
Sep 14, 2022Cipla
Lack of Assurance of Sterility		Class II · Terminated
Jan 10, 2013AstraZeneca LP
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.		Class III · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).