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 RemedyRepack 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 RemedyRepack Inc. directly.
Affected Products
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
Quantity: a) 1,564 cards, b) 799 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 RemedyRepack Inc.
RemedyRepack Inc. has 60 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report