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 proposed interim...
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, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10
Quantity: 3,591 bottles
Why Was This Recalled?
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Where Was This Sold?
This product was distributed to 3 states: AZ, IN, NJ
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