Class II

Drug Recall: Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.

Glenmark Pharmaceuticals Inc., USA · January 29, 2025

Reason for Recall

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

Distribution

Nationwide within the U.S

States Affected

NATIONWIDE

Quantity Affected

120,000 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0238-2025

Status: ongoing

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