Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90) recall — FDA D-0388-2025
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Complete FDA and NHTSA recall records dated in 2025, 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 Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Chrysler (FCA US, LLC) is recalling certain 2017-2019 Jeep Cherokee vehicles. The power transfer unit (PTU) may become damaged and disengage the transmission and differential, resulting in…
General Motors LLC (GM) is recalling certain 2021-2024 Cadillac Escalade and Escalade ESV, Chevrolet Silverado 1500, Suburban, and Tahoe, GMC Sierra 1500, Yukon, and Yukon XL vehicles…
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies…
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Ford Motor Company (Ford) is recalling certain 2025 F-150 vehicles. The air bag warning label may be missing from the dashboard. As such, these vehicles fail to comply with the requirements…
BMW of North America, LLC (BMW) is recalling certain 2025 X3 30 xDrive vehicles. The front brake discs may have been damaged during transport before they were installed on the vehicle.
Chemical contamination: Presence of benzene
Lack of Assurance of Sterility: Media fill with bacterial contamination
Cross Contamination
Presence of Particulate Matter
Chemical contamination: Presence of benzene
Lack of Assurance of Sterility: Media fill with bacterial contamination
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Cross Contamination
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Chrysler (FCA US, LLC) is recalling certain 2025 Ram 1500 vehicles. A software error may cause an incorrect tire inflation pressure message to display on the instrument panel.
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
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.