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13 reported ongoing
24 records in this archive. Latest source date Sep 12, 2025.
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 Desmethyl Chlorpromazine above the recommended intake limit
Class IIReported ongoing
Distribution: Nationwide
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class IIReported ongoing
Distribution: Nationwide
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class IIReported ongoing
Distribution: Nationwide
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class IIReported ongoing
Distribution: Nationwide
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class IIReported ongoing
Distribution: Nationwide
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class IIReported ongoing
Distribution: USA Nationwide.
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class IIReported ongoing
Distribution: USA Nationwide.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class IIReported ongoing
Distribution: Product was distributed nationwide within the United States.
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class IIReported ongoing
Distribution: Nationwide USA
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Class IIIReported terminated
Distribution: Nationwide in the USA
Failed Dissolution Specifications.
Class IIReported ongoing
Distribution: Nationwide in the USA
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class IIReported ongoing
Distribution: Nationwide U.S. and Puerto rico
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class IIReported ongoing
Distribution: Nationwide U.S. and Puerto rico
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class IIReported ongoing
Distribution: Nationwide U.S. and Puerto rico
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Class IIReported terminated
Distribution: Nationwide within the United States
Failed Impurity/Degradation Specifications
Class IIReported terminated
Distribution: Nationwide within the United States
Failed Impurity/Degradation Specifications
Class IIReported terminated
Distribution: Nationwide within the United States
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Class IIIReported terminated
Distribution: Nationwide in the US.
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Class IIReported terminated
Distribution: Nationwide. No foreign consignees.
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Class IIReported terminated
Distribution: The product was distributed nationwide within the United States.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 24 records, including 13 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.