Rising Pharma recalls 30-count and 1000-count Duloxetine 30mg capsules due to potential N-nitroso-duloxetine impurity above safety limits. This may pose health risks.
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma is recalling two sizes of Duloxetine 30mg capsules because they contain an impurity that could be unsafe. This is a medication recall for people with prescriptions.
The capsules contain an impurity called N-nitroso-duloxetine that exceeds safety limits. This impurity could potentially cause health issues, though the exact risk level isn't clearly stated in the recall.
People who have a prescription for Duloxetine 30mg capsules and received these specific bottle sizes from the manufacturer. Those taking the medication are at risk if they use the recalled products.
Check your prescription bottle for the product name 'Duloxetine Delayed-Release Capsules USP 30 mg' and the specific lot numbers DT3023051A (expiring April 2025) or DT3023025A (expiring January 2025).
Look for the lot numbers DT3023051A (expiring April 2025) or DT3023025A (expiring January 2025) on the bottle.
The product contains an impurity called N-nitroso-duloxetine that exceeds safety limits, which could pose health risks.
Check the bottle for the product name 'Duloxetine Delayed-Release Capsules USP 30 mg' and the specific lot numbers DT3023051A (expiring April 2025) or DT3023025A (expiring January 2025).
The recall record does not specify a remedy, so contact Rising Pharma directly for guidance.
We’ve drafted a message you can send Rising Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0188-2025 — Rising Pharma Rising Pharma Hello, I own a Rising Pharma that is covered by recall D-0188-2025 from Rising Pharma. 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.
