Amerisource Health Services LLC recalls Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hy
Recalled January 1, 2025 · FDA recall D-0157-2025 · Amerisource Health Services
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. · FDA Class II
Units
20,734 30-count bottles
Sold at
Nationwide in the USA
Description
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Product
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04
Manufacturer(s)
Amerisource Health Services LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →