MedicineWatch US
Class II Recall

Glenmark Pharmaceuticals Inc., USA

Product
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.
Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Classification
Class II
Status
Ongoing
Lot
Lot Numbers: 19234153, Exp.: 9/2025; 19234900, 19234929, Exp.: 11/2025; 19240936, 19240942, Exp.: 2/2026; 19243199, 19243190, Exp.:7/2026; 19244013, 19244014, Exp.: 9/2026.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Glenmark Pharmaceuticals Inc., USA — Class II Recall | MedicineWatch US