Class IIReported 2025-02-26

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

Recalled by Glenmark Pharmaceuticals Inc., USA

Reason for Recall

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

Recall Number

D-0234-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-01-29

Reported

2025-02-26

Distribution

Nationwide within the U.S

Code Info

Lot Numbers: 19234109, Exp.: 9/2025; 19234897, Exp.: 11/2025; 19240501, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19241806, Exp.: 4/2026.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.