Check your batch Filed 2026-06-10
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
Check these codes: Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
50 bottles · distributed us nationwide. Recall D-0555-2026 on FDA.gov ↗