FDAFDA · Food and drugs·Recall number D-0232-2025
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.
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
- 0368462265307
- Lot
- Lot Numbers: 19233756, Exp.: 8/2025; 19235111, Exp.: 11/2025; 19242167, Exp.: 5/2026; 19242180, Exp.: 5/2026.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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