Class II
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
- Recall number
- D-0155-2025
- Report date
- January 1, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Amerisource Health Services LLC
- Generic names
- Not provided
- Brand names
- Not provided
- Product NDCs
- Not provided
Code and lot information
Lot DT3023029A Exp 02/28/2025
Distribution
Nationwide in the USA
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.