Duloxetine Delayed-Release Capsules, USP, 60mg recall — FDA D-0583-2026
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Complete FDA and NHTSA recall records dated in 2026, organized for browsing by month, category and recalling company.
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Records are ordered by the best available source date.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Premature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste.
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Contains undeclared allergen (shrimp).
The ingredient, Pista, currently declared on our label should be corrected to the standard American nomenclature, Pistachio.
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Imported Enoki Mushrooms tested positive for Listeria Monocytogenes.
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Potential contamination with lead.
Undeclared FD&C Red 40
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.