Asclemed USA recalls 30mg Duloxetine DR Capsules due to nitrosamine impurity exceeding FDA limits. Consumers should check product labels for NDC 76420-634-30 and lot numbers 050725F-30 or 050725G-30.
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Asclemed USA is recalling Duloxetine DR Capsules (30 mg, 30-count bottles) because they contain a nitrosamine impurity that exceeds the FDA's safe limit. This could pose a health risk if taken regularly.
The capsules contain N-nitroso-duloxetine, a nitrosamine impurity that exceeds the FDA's acceptable intake limit. This impurity could potentially cause health issues with long-term use, though the exact risk level isn't specified in the recall.
People who have the specific Duloxetine capsules with NDC 76420-634-30 and lot numbers 050725F-30 or 050725G-30 are affected. Those taking this medication for depression or nerve pain are most at risk.
Check the product label for the NDC number 76420-634-30 and lot numbers 050725F-30 or 050725G-30. The capsules are marketed by Ajanta Pharma USA Inc. and relabeled by Enovachem Pharmaceuticals.
Look for the NDC number 76420-634-30 and lot numbers 050725F-30 or 050725G-30 on the packaging.
The recall states the product contains a nitrosamine impurity above FDA limits, but the official notice doesn't specify if it's safe to take.
Check the product label for NDC 76420-634-30 and lot numbers 050725F-30 or 050725G-30.
The recall doesn't specify a remedy, so the official notice doesn't say what to do next.
We’ve drafted a message you can send Asclemed USA to request your refund or repair — edit it as you like.
Subject: Recall D-0555-2026 — Asclemed USA Asclemed USA Hello, I own a Asclemed USA that is covered by recall D-0555-2026 from Asclemed USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
