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Antidepressants

FDA recalls

38 rows

DateCompany and reasonClass
Sep 22, 2026Apotex Corp.
Failed dissolution specifications.		Class II · Ongoing
Aug 23, 2026Teva Pharmaceuticals USA, Inc
Presence of Foreign Tablets/Capsules		Class II · Ongoing
Jun 3, 2026Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit		Class II · Ongoing
May 13, 2026Asclemed USA Inc.
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.		Class II · Ongoing
Apr 28, 2026Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.		Class II · Ongoing
Apr 20, 2026Breckenridge Pharmaceutical, Inc.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit		Class II · Ongoing
Jan 25, 2026Granules Pharmaceuticals Inc.
Presence of Foreign Tablets/Capsules		Class II · Ongoing
Dec 18, 2025Zydus Pharmaceuticals (USA) Inc
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.		Class III · Ongoing
Nov 23, 2025Breckenridge Pharmaceutical, Inc.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit		Class II · Ongoing
Nov 4, 2025Lupin Pharmaceuticals Inc.
Defective container - seal not adhering to bottles		Class II · Ongoing
Oct 8, 2025Breckenridge Pharmaceutical, Inc.
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.		Class II · Ongoing
Aug 7, 2025Breckenridge Pharmaceutical, Inc.
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.		Class II · Ongoing
Jul 24, 2025Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.		Class II · Ongoing
Jul 14, 2025Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit		Class II · Ongoing
Jun 29, 2025Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit		Class II · Ongoing
Apr 13, 2025Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.		Class II · Ongoing
Mar 25, 2025Breckenridge Pharmaceutical, Inc.
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.		Class II · Ongoing
Feb 27, 2025Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.		Class II · Ongoing
Dec 5, 2024Breckenridge Pharmaceutical, Inc
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.		Class II · Ongoing
Oct 9, 2024Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit		Class II · Completed
Jun 20, 2024Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.		Class II · Terminated
May 16, 2024Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit		Class II · Terminated
Apr 28, 2024Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit		Class II · Ongoing
Dec 10, 2023Legacy Pharmaceutical PAckaging LLC
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.		Class II · Ongoing
Dec 26, 2022Amerisource Health Services LLC
Failed Impurities/Degradation Specifications		Class II · Terminated
Jan 25, 2022Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.		Class II · Terminated
Mar 14, 2021Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.		Class II · Terminated
Mar 17, 2020Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed		Class II · Terminated
Nov 19, 2019Auromedics Pharma LLC
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.		Class I · Terminated
Nov 20, 2017Lupin Pharmaceuticals Inc.
Failed Dissolution Specification		Class III · Terminated
Jun 21, 2017Lupin Pharmaceuticals Inc.
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.		Class III · Terminated
Jan 26, 2017Mylan Institutional, Inc. (d.b.a. Udl Laboratories)
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled		Class II · Terminated
Jan 18, 2017Mylan Pharmaceuticals Inc.
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle		Class II · Terminated
Dec 21, 2016Aurobindo Pharma USA Inc
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.		Class II · Terminated
Jul 18, 2016Zydus Pharmaceuticals USA Inc
Failed Dissolution Specifications: out of specification dissolution results in retained samples		Class II · Terminated
Mar 23, 2016Lupin Limited
Labeling: Incorrect or Missing Lot and/or Expiration Date		Class III · Terminated
Oct 20, 2015Breckenridge Pharmaceutical, Inc
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle		Class III · Terminated
Mar 23, 2014Apotex Inc.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.		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).