Rising Pharma recalls 20mg Duloxetine capsules due to potential N-nitroso impurity above safety limits. Rx-only bottles with specific lot numbers and expiration dates are affected.
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma is recalling 20mg Duloxetine Delayed-Release Capsules bottles that may contain unsafe levels of N-nitroso-duloxetine. This impurity could pose health risks if taken, so affected users should stop using the product.
The capsules may contain N-nitroso-duloxetine impurities above the recommended safety limit. This impurity could potentially cause health issues if the medication is taken as prescribed.
Prescription users of Duloxetine 20mg capsules with specific lot numbers and expiration dates. People taking this medication for depression or nerve pain are most at risk.
Check for the product name 'Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles' with lot numbers DT2023003A, DT2023007A, or DT2023008A and expiration date January 2025.
Look for the lot numbers DT2023003A, DT2023007A, or DT2023008A on the bottle label.
If the product matches the recalled details, stop using the capsules immediately.
No, the recalled capsules may contain unsafe levels of N-nitroso-duloxetine impurities. Do not take these capsules.
Stop using the capsules immediately and contact Rising Pharma for further instructions.
Check the lot numbers on the bottle: DT2023003A, DT2023007A, or DT2023008A with expiration date January 2025.
We’ve drafted a message you can send Rising Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0189-2025 — Rising Pharma Rising Pharma Hello, I own a Rising Pharma that is covered by recall D-0189-2025 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.
