Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atomoxetine Capsules Recalled by Glenmark Pharmaceuticals Inc., USA Due to CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above...
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 Glenmark Pharmaceuticals Inc., USA directly.
Affected Products
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.
Quantity: 53,952 bottles
Why Was This Recalled?
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Glenmark Pharmaceuticals Inc., USA
Glenmark Pharmaceuticals Inc., USA has 139 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report