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Adalimumab

FDA recalls

6 rows

DateCompany and reasonClass
Jan 19, 2026Acme United Corporation
CGMP Deviations
Class II · Ongoing
Jul 6, 2025Medline Industries, LP - Northfield
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Ongoing
Feb 16, 2025Medline Industries, LP - Northfield
Subpotent Drug
Class II · Ongoing
Mar 15, 2023Focus Health Group Inc
Labeling; Incorrect NDC number on outer carton of product.
Class III · Ongoing
Jun 28, 2022McKesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Terminated
Mar 27, 2019Aurobindo 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).