FDAFDA · Food and drugs·Recall number D-0567-2025
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
Published August 13, 2025 · Recall initiated: March 7, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Direct Rx
- Distributor
- Nationwide
- Lot
- Lot #: 02AU2406, Exp 01/31/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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