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Naproxen

FDA recalls

5 rows

Date	Company and reason	Class
Apr 19, 2026	Acella Pharmaceuticals, LLC Chemical contamination; presence of lead and lithium above specification	Class II · Ongoing
Mar 12, 2025	Glenmark Pharmaceuticals Inc., USA CGMP Deviations	Class II · Ongoing
Nov 6, 2023	Glenmark Pharmaceuticals Inc., USA Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen	Class II · Ongoing
Aug 26, 2021	Glenmark Pharmaceuticals Inc., USA CGMP Deviations	Class II · Terminated
Jul 5, 2012	Glenmark Generics Inc., USA Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.	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).