Antidepressant recalls
61 FDA-recorded recalls of antidepressants, most recent Jun 2026 — newest first, straight from the FDA's own database.
Antidepressant recalls are typically manufacturing, packaging or potency failures affecting specific lots, not a safety problem with the drug. Stopping an antidepressant abruptly can cause a discontinuation syndrome, so if your product is recalled, do not simply stop — confirm the lot against the FDA notice and ask your pharmacist about a replacement.
DULOXETINE D/R
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Direct Rx · Jul 1, 2026
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc. · Jun 17, 2026
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc. · Jun 17, 2026
Duloxetine DR Capsules
Class IICGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Asclemed USA Inc. · Jun 10, 2026
Duloxetine Delayed-Release Capsules
Class IICGMP 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.
Ajanta Pharma Ltd. · May 13, 2026
Duloxetine Delayed-Release Capsules
Class IICGMP 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.
Ajanta Pharma Ltd. · May 13, 2026
Duloxetine Delayed-Release Capsules
Class IICGMP 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.
Ajanta Pharma Ltd. · May 13, 2026
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical, Inc. · May 13, 2026
Trazodone Hydrochloride
Class IIPresence of Foreign Tablets/Capsules
Granules Pharmaceuticals Inc. · Feb 11, 2026
traZODONE Hydrochloride Tablets
Class IIIFailed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Zydus Pharmaceuticals (USA) Inc · Jan 7, 2026
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical, Inc. · Dec 10, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical, Inc. · Dec 10, 2025
Sertraline Hydrochloride Tablets USP
Class IIDefective container - seal not adhering to bottles
Lupin Pharmaceuticals Inc. · Dec 17, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Breckenridge Pharmaceutical, Inc. · Nov 5, 2025
Bupropion Hydrochloride Extended-Release Tablets USP (XL)
Class IIFailed Tablet/Capsule Specifications
Graviti Pharmaceuticals Private Limited · Oct 29, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Breckenridge Pharmaceutical, Inc. · Sep 17, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical, Inc. · Aug 20, 2025
Doxepin Hydrochloride Capsules
Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Alembic Pharmaceuticals Limited · Aug 13, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Breckenridge Pharmaceutical, Inc. · Aug 13, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc. · Jul 16, 2025
Fluoxetine Tablets
Class IICGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Torrent Pharma Inc. · Jun 11, 2025
Fluoxetine Tablets
Class IICGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Torrent Pharma Inc. · Jun 11, 2025
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Breckenridge Pharmaceutical, Inc · Apr 30, 2025
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Breckenridge Pharmaceutical, Inc · Apr 30, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Breckenridge Pharmaceutical, Inc. · Apr 9, 2025
Venlafaxine Tablets
Class IIPresence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Zydus Pharmaceuticals (USA) Inc · Apr 16, 2025
Duloxetine D/R
Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Direct Rx · Aug 13, 2025
Duloxetine D/R
Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Direct Rx · Aug 13, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma Holding, Inc. · Mar 26, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical, Inc. · Mar 19, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical, Inc. · Mar 19, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical, Inc. · Mar 19, 2025
Venlafaxine Extended-Release Tablets
Class IIIFailed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Appco Pharma LLC · Jan 29, 2025
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Feb 5, 2025
Duloxetine DR Capsules USP 60 mg
Class IICGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma Holding, Inc. · Jan 15, 2025
Duloxetine Delayed-Release Capsules USP 30 mg
Class IICGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma Holding, Inc. · Jan 15, 2025
Duloxetine Delayed-Release Capsules USP 20 mg
Class IICGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma Holding, Inc. · Jan 15, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical, Inc · Jan 1, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Amerisource Health Services LLC · Jan 1, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical, Inc · Jan 1, 2025
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Amerisource Health Services LLC · Jan 1, 2025
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Amerisource Health Services LLC · Jan 1, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Amerisource Health Services LLC · Jan 1, 2025
DULoxetine DR USP
Class IICGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
PD-Rx Pharmaceuticals, Inc. · Jan 1, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
RemedyRepack Inc. · Jan 1, 2025
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Rising Pharma Holding, Inc. · Dec 11, 2024
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Rising Pharma Holding, Inc. · Dec 11, 2024
Duloxetine DR Capsules USP 60 mg
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Rising Pharma Holding, Inc. · Dec 11, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Amerisource Health Services LLC · Dec 11, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Amerisource Health Services LLC · Dec 11, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Amerisource Health Services LLC · Dec 11, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc · Oct 23, 2024
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily
Class IIFailed Dissolution Specifications; the product is dissolving faster than the specified limits.
Amerisource Health Services LLC · Jul 17, 2024
Venlafaxine Hydrochloride Extended-Release Capsules
Class IIFailed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Zydus Pharmaceuticals (USA) Inc · Jul 31, 2024
Venlafaxine Hydrochloride
Class IIFailed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Jul 10, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc · Jun 26, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Golden State Medical Supply Inc. · Jul 3, 2024
Duloxetine Delayed-Release Cap USP 30mg
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Preferred Pharmaceuticals, Inc. · May 29, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc · May 15, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc · May 15, 2024
How to use this page
A drug appearing here does not mean your prescription is unsafe. Recalls name specific lots and manufacturers — open the recall to see the affected lot numbers, and match them against your bottle. Never stop a blood-pressure, cholesterol, diabetes, antidepressant or antibiotic medicine on your own because of a recall; confirm your lot, then ask your pharmacist for a replacement if it is affected.
Other categories: Blood pressure medication · Eye drop and ophthalmic · Cholesterol medication · Diabetes medication · Antibiotic. See also the full recalls tracker and the recall report.
Source: the openFDA drug Enforcement (recall) database. Recalls are matched to this category by the drug names in the FDA’s product description; a small number of category recalls may be missed if the description omits the ingredient. Figures are recall events, not units, and reflect our copy of the FDA data, refreshed daily. This is public regulatory data, not medical advice.