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21 reported ongoing
29 records in this archive. Latest source date Jun 4, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class IIReported ongoing
Distribution: Nationwide within the United States
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class IIReported ongoing
Distribution: Nationwide within the United States
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class IIReported ongoing
Distribution: Nationwide in the USA
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class IIReported ongoing
Distribution: Nationwide within the United States
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class IIReported ongoing
Distribution: Nationwide within the United States
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Class IIReported ongoing
Distribution: U.S. Nationwide
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Class IIReported ongoing
Distribution: AZ, IN, NJ
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class IIReported ongoing
Distribution: NJ, AZ, IN
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Class IIReported ongoing
Distribution: U.S Nationwide
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class IIReported ongoing
Distribution: U.S. Nationwide
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class IIReported ongoing
Distribution: US Nationwide.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class IIReported ongoing
Distribution: US Nationwide.
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Class IIReported ongoing
Distribution: Nationwide in the US
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class IIReported ongoing
Distribution: Nationwide
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class IIReported ongoing
Distribution: Nationwide
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class IIReported ongoing
Distribution: Nationwide
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class IIReported ongoing
Distribution: Nationwide in the US
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class IIReported ongoing
Distribution: Nationwide in the US
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class IIReported completed
Distribution: Product was distributed nationwide within the United States
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class IIReported terminated
Distribution: Nationwide in the USA
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 29 records, including 21 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.