⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Asclemed USA Inc.: Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed

DrugsSource: FDA (drug) · Date: 2026-06-10

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Asclemed USA Inc.
Product
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.
Reason / hazard
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide.
Recall initiated
2026-05-14
Code info
Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
Product quantity
50 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Torrance
State
CA
Country
United States
Event id
99019
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