Asclemed Duloxetine Capsules Recall: Nitrosamine Impurity Risk
Asclemed USA recalls 30mg Duloxetine DR Capsules due to nitrosamine impurity exceeding FDA limits. Consumers should check product labels for NDC 76420-634-30 and lot numbers 050725F-30 or 050725G-30.
Recall notice
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Contact the company
What happened, in plain English
Asclemed USA is recalling Duloxetine DR Capsules (30 mg, 30-count bottles) because they contain a nitrosamine impurity that exceeds the FDA's safe limit. This could pose a health risk if taken regularly. Read more at govinfonow.com/recall/31309-asclemed-duloxetine-capsules-recall-nitrosamine-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31309-asclemed-duloxetine-capsules-recall-nitrosamine-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0555-2026
Cite this page
“Asclemed Duloxetine Capsules Recall: Nitrosamine Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31309-asclemed-duloxetine-capsules-recall-nitrosamine-impurity-risk. Based on FDA recall #D-0555-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0555-2026%22&limit=1).
Why it’s dangerous
The capsules contain N-nitroso-duloxetine, a nitrosamine impurity that exceeds the FDA's acceptable intake limit. This impurity could potentially cause health issues with long-term use, though the exact risk level isn't specified in the recall.
Who’s affected
People who have the specific Duloxetine capsules with NDC 76420-634-30 and lot numbers 050725F-30 or 050725G-30 are affected. Those taking this medication for depression or nerve pain are most at risk.
How to tell if you have this one
Check the product label for the NDC number 76420-634-30 and lot numbers 050725F-30 or 050725G-30. The capsules are marketed by Ajanta Pharma USA Inc. and relabeled by Enovachem Pharmaceuticals.
- Brand
Asclemed USA- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC number 76420-634-30 and lot numbers 050725F-30 or 050725G-30 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US 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 27 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.
Similar recalls
Latest drug recalls
Keep exploring
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-0555-2026 (May 14, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0555-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.