Recall: D-0244-2025

Class II - Potentially Harmful

Class IIClassification

2025-01-29Initiated

OngoingStatus

Glenmark Pharmaceuticals Inc.,Firm

Product

Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.

Reason

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

Distribution

Nationwide within the U.S

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.