FDAFDA · Food and drugs·Recall number D-0238-2025
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.
Published February 26, 2025 · Recall initiated: January 29, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ATOMOXETINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Nationwide within the U.S
- UPC
- 0316714760018
- Lot
- Lot Numbers: 19232356, Exp.: 5/2025; 19233198, Exp.: 7/2025; 19234213, 19234232, Exp.: 9/2025; 19241445, Exp.: 3/2026; 19243033, 19243121, Exp.: 7/2026.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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