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 FDA...
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, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Quantity: 281,554/90 & 1000 count bottles
Why Was This Recalled?
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Breckenridge Pharmaceutical, Inc
Breckenridge Pharmaceutical, Inc has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report