Recalls / Class II

Class IID-0157-2025

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

Affected lot / code info

Lot DT6023061B Exp 01/31/2025

Why it was recalled

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

Recalling firm

Firm

Amerisource Health Services LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188

Distribution

Quantity

20,734 30-count bottles

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2024-12-06

FDA classified

2024-12-23

Posted by FDA

2025-01-01

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0157-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.