Class II
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Recall number
- D-0567-2025
- Report date
- August 13, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Direct Rx
- Generic names
- Not provided
- Brand names
- Not provided
- Product NDCs
- Not provided
Code and lot information
Lot #: 02AU2406, Exp 01/31/2027
Distribution
Nationwide
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.