Direct Rx recalls DULOXETINE D/R 30mg capsules (NDC 61919-482-30) and 60-capsule packs (NDC 61919-482-60) due to N-nitroso-duloxetine impurity exceeding FDA safety limits. Affected lots expire 04/30/2027.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Direct Rx is recalling specific DULOXETINE D/R and CYMBALTA products due to a chemical impurity that could pose a health risk. This impurity may exceed safe levels, though the exact risk level isn't specified in the recall.
The recall is for a chemical impurity called N-nitroso-duloxetine that may be present above the FDA's recommended safety limit. This impurity could potentially cause health issues, but the exact risk level isn't clearly stated in the recall notice.
People who purchased the recalled DULOXETINE D/R 30mg capsules (NDC 61919-482-30) or 60-capsule packs (NDC 61919-482-60) from Direct Rx. Those with the specific lot numbers listed are most at risk.
Check your DULOXETINE D/R 30mg capsules (NDC 61919-482-30) or 60-capsule packs (NDC 61919-482-60) for the lot numbers: 09JA2530, 31JA2507 (for 30-capsule packs) or 09DE2412, 09JA2528, 29JA2511 (for 60-capsule packs). The products expire by 04/30/2027.
Look for lot numbers 09JA2530, 31JA2507 on 30-capsule packs or 09DE2412, 09JA2528, 29JA2511 on 60-capsule packs.
The recall states the impurity may exceed FDA safety limits, but the exact health risk isn't specified in the notice.
The recall doesn't specify a remedy, so the official notice doesn't say what action to take.
Check the lot numbers on your DULOXETINE D/R 30mg capsules (NDC 61919-482-30) or 60-capsule packs (NDC 61919-482-60) against the listed numbers: 09JA2530, 31JA2507 or 09DE2412, 09JA2528, 29JA2511.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0617-2026 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0617-2026 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.
