Class IIReported 2025-02-26

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.

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-0240-2025

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: 19232506, 19232397, 19232415, Exp.: 5/2025; 19233791, Exp.: 8/2025; 19234248, Exp.: 9/2025; 19240909, Exp.: 2/2026; 19242598, Exp.:6/2026; 19243163, 19243122, Exp.: 7/2026; 19243884, Exp.: 9/2026.

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