Class II

Drug Recall: Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06

Amerisource Health Services LLC · November 14, 2024

Reason for Recall

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

Distribution

PA, OH, PR

States Affected

OH, PA

Quantity Affected

37,916 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0099-2025

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.