Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Duloxetine Delayed-Release Capsules Recalled by Breckenridge Pharmaceutical, Inc. Due to CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment...
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 Breckenridge Pharmaceutical, Inc. directly.
Affected Products
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
Quantity: 172,263 bottles
Why Was This Recalled?
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Breckenridge Pharmaceutical, Inc.
Breckenridge Pharmaceutical, Inc. has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report