Direct Rx recalls 20mg Duloxetine 30-count bottles due to nitrosamine impurity exceeding safety limits. Consumers should check lot numbers and contact the manufacturer for details.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Direct Rx is recalling 20mg Duloxetine 30-count bottles because they contain a harmful nitrosamine impurity above safety limits. This could pose a health risk to users, so affected individuals should stop using the product and contact the manufacturer.
The product contains a nitrosamine impurity that exceeds the safety limit set by regulatory standards. Nitrosamines are known to be harmful and can potentially cause health issues when consumed in high amounts.
People who have the specific 20mg Duloxetine 30-count bottle with lot number 02AU2406 (expiring Jan 2027) are affected. Those using this medication for depression or other conditions are at risk.
Check for the 20mg Duloxetine 30-count bottle with lot number 02AU2406 (expiring Jan 2027). The product is distributed by Direct Rx and sold through pharmacies in the US.
Identify the lot number on the bottle, which should be 02AU2406 for this recall.
Reach out to Direct Rx for further instructions on how to return or dispose of the product.
The recall indicates the product contains a nitrosamine impurity above safety limits, so it is not safe to use.
Check for the 20mg Duloxetine 30-count bottle with lot number 02AU2406 (expiring Jan 2027).
Contact Direct Rx for instructions on returning or disposing of the product.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0567-2025 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0567-2025 from Direct Rx. 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.
