Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Duloxetine Delayed-Release Capsules USP 20 mg Recalled by Rising Pharma Holding, Inc. Due to CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended...
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 Rising Pharma Holding, Inc. directly.
Affected Products
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Quantity: 73,680 bottles
Why Was This Recalled?
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Rising Pharma Holding, Inc.
Rising Pharma Holding, 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