Direct Rx recalls 30mg Duloxetine capsules due to nitrosamine impurity exceeding safety limits. Affected lots include specific NDC numbers and expiration dates. Consumers should stop using and consult a healthcare provider.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Direct Rx is recalling 30mg Duloxetine capsules that contain a harmful nitrosamine impurity above safety limits. This could pose a health risk, so affected users should stop taking the medication and contact their doctor.
The capsules contain a nitrosamine impurity that exceeds the proposed interim safety limit. Nitrosamines are known to be carcinogenic, meaning they can cause cancer when ingested over time. This impurity was found during manufacturing quality checks.
People who have purchased the recalled Duloxetine capsules from Direct Rx, including specific NDC numbers and expiration dates. Those with prescriptions for this medication are most at risk.
Check for the product name 'Duloxetine D/R', 30mg, 30 capsules, with NDC numbers 61919-0482-30, 61919-0482-60, or 61919-0482-90. The affected lots have specific expiration dates and batch numbers listed in the recall notice.
Immediately stop taking the recalled Duloxetine capsules and contact your healthcare provider for alternative treatment options.
The recall is due to the presence of nitrosamine impurities in the medication that exceed the proposed interim safety limits, which could pose a cancer risk.
The affected products are Duloxetine D/R 30mg capsules with NDC numbers 61919-0482-30, 61919-0482-60, and 61919-0482-90, with specific lot numbers and expiration dates listed in the recall notice.
Check the product label for the NDC numbers mentioned in the recall and compare the lot numbers and expiration dates provided in the notice.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0568-2025 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0568-2025 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.
