Class II

Drug Recall: 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

Amerisource Health Services LLC · December 6, 2024

Reason for Recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

20,734 30-count bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0157-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.