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Buprenorphine

FDA recalls

3 rows

DateCompany and reasonClass
Aug 18, 2026American Health PAckaging
Labeling: Label Mix-up
Class III · Ongoing
May 2, 2023Sun Pharmaceutical Industries Inc
CGMP Deviations
Class II · Terminated
Sep 3, 2020Teva Pharmaceuticals USA
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Class II · 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).