Class II

Drug Recall: Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.

Glenmark Pharmaceuticals Inc., USA · January 29, 2025

Reason for Recall

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

Distribution

Nationwide within the U.S

States Affected

NATIONWIDE

Quantity Affected

190,320 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0234-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.