Class IIReported 2025-02-26

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

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-0233-2025

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