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Olanzapine

FDA recalls

4 rows

DateCompany and reasonClass
Aug 26, 2026Macleods Pharmaceuticals Limited
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Class III · Ongoing
Nov 24, 2024Macleods Pharmaceuticals Ltd
Failed Impurities/Degradation Specifications
Class II · Ongoing
Feb 15, 2022Macleods Pharma Usa Inc
cGmp Deviations
Class II · Terminated
Oct 12, 2016Dr. Reddy's Laboratories, Inc.
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
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).