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; presence of N-nitroso-duloxetine impurity above the...
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, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Quantity: 7389 bottles
Why Was This Recalled?
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
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