Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,
Recalled February 26, 2025 · FDA recall D-0231-2025 · Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. · FDA Class II
Units
70,032 bottles
Sold at
Nationwide within the U.S
Description
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Product
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →