Reported Jun 10, 2026 · Ongoing
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC…
Asclemed USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Asclemed USA Inc. · 379 Van Ness Ave Ste 1403 · Torrance, CA · 90501-7211
Is this the product you have?
- Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx
- Relabeled byEnovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30
- Marketed byAjanta Pharma USA Inc
- Lot codes and dates
- Lot # 050725G-30 & 050725F-30
- Exp Date06/30/2026
- Amount recalled
- 50 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
This product could cause temporary or reversible health problems — stop using it.
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