Direct Rx DULOXETINE D/R 30mg Caps Recall: N-nitroso-duloxetine Impurity Risk
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.
Recall notice
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/31194-direct-rx-duloxetine-d-r-30mg-caps-recall-n-nitroso.
Source Summary by GovInfoNow · govinfonow.com/recall/31194-direct-rx-duloxetine-d-r-30mg-caps-recall-n-nitroso · Updated August 9, 2026 · FDA enforcement record: FDA #D-0617-2026
Cite this page
“Direct Rx DULOXETINE D/R 30mg Caps Recall: N-nitroso-duloxetine Impurity Risk.” GovInfoNow, updated August 9, 2026. https://govinfonow.com/recall/31194-direct-rx-duloxetine-d-r-30mg-caps-recall-n-nitroso. Based on FDA recall #D-0617-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0617-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Direct Rx- Category
Drug
What to do — step by step
Check Product Lot Numbers
Look for lot numbers 09JA2530, 31JA2507 on 30-capsule packs or 09DE2412, 09JA2528, 29JA2511 on 60-capsule packs.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 9 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #D-0617-2026 (June 22, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0617-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.