Glenmark Pharmaceuticals Inc., USA: Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.

Hazard

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Details from the source

Reason for recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Distribution: Nationwide within the U.S Quantity: 175,920 bottles Lot/code info: Lot Numbers: 19233792, Exp.: 8/2025; 19233795, Exp.: 8/2025; 19234258, Exp.: 9/2025; 19240912, Exp.: 2/2026; 19241476, 19241477, Exp.: 3/2026; 19242599, Exp.: 6/2026; 19243163, 19243162, Exp.:7/2026;19243884, 19243887, Exp.:9/2026.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.