Class IIReported 2025-02-26
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
Recalled by Glenmark Pharmaceuticals Inc., USA
Reason for Recall
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Advertisement
Recall NumberD-0237-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2025-01-29Reported2025-02-26DistributionNationwide within the U.SCode InfoLot Numbers: 19234955, 19234956, Exp.: 11/2025; 19240971, Exp.: 2/2026; 19241864, Exp.: 4/2026.Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.