Asclemed USA Inc. recalls Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabel
See all recalls from Asclemed USA Inc. →Recalled 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.
Hazard / Issue
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
✅ What Should You Do?
- 1Stop taking this medication and contact your doctor or pharmacist immediately.
- 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
- 3Check the lot number on your bottle or packaging against the recalled lots listed above.
- 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Duloxetine DR Capsules, 30 →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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