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Adalimumab
FDA recalls
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Date Company and reason Class
Jan 19, 2026 Acme United Corporation CGMP DeviationsClass II · Ongoing Jul 6, 2025 Medline Industries, LP - Northfield Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.Class II · Ongoing Feb 16, 2025 Medline Industries, LP - Northfield Subpotent DrugClass II · Ongoing Mar 15, 2023 Focus Health Group Inc Labeling; Incorrect NDC number on outer carton of product.Class III · Ongoing Jun 28, 2022 McKesson Medical-Surgical Inc. Corporate Office CGMP Deviations: products were stored outside the drug label specifications.Class II · Terminated Mar 27, 2019 Aurobindo Pharma USA Inc. Presence of Particulate Matter: One vial was found to contain a hair.Class I · 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).