Class IIReported 2025-02-26
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.
Recalled by Glenmark Pharmaceuticals Inc., USA
Reason for Recall
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
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Recall NumberD-0235-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2025-01-29Reported2025-02-26DistributionNationwide within the U.SCode InfoLot Numbers: 19234630, Exp.: 10/2025; 19240528, 19240529, Exp.: 1/2026.Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.