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.

Recall Number: D-0240-2025

Firm: Glenmark Pharmaceuticals Inc., USA

Classification: Class II

Status: Ongoing

Report Date: 20250226

Initiation Date: 20250129

Termination Date:

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

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.