Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Duloxetine D/R Recalled by Direct Rx Due to CGMP Deviations: Presence of Nitrosamine Drug Substance Related...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Direct Rx directly.
Affected Products
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
Quantity: 16 bottles
Why Was This Recalled?
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Direct Rx
Direct Rx has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report