Class IIReported 2025-02-26

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.

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-0239-2025

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: 19233228, 19233227, Exp.: 7/2025; 19233757, Exp.: 8/2025; 19234229, Exp.: 9/2025; 19235090, Exp.: 11/2025; 19241471, Exp.:3/2026; 19242180, Exp.: 5/2026.

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