FDA recall, , Moderate risk
Asclemed USA Duloxetine DR Capsules
Duloxetine DR Capsules contain a nitrosamine impurity above the acceptable limit.
Summary by Recall Canary from the FDA notice
What happened
Asclemed USA Inc., of Torrance, California, recalled Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, relabeled by Enovachem Pharmaceuticals and marketed by Ajanta Pharma USA Inc., due to CGMP deviations and the presence of the nitrosamine drug substance related impurity N-nitroso-duloxetine above the FDA acceptable intake limit. The recall began May 14, 2026, and was classified by the FDA on June 2, 2026, with the product distributed nationwide.
The recalled product was distributed across the United States. The FDA added the recall to its Enforcement Report on June 3, 2026, and included it in the weekly enforcement report on June 10, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 76420-634-30
- Lot code
- 050725G-30
- 050725F-30
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Asclemed USA Inc.Torrance, California
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99019
- Recall number
- D-0555-2026
- Quantity recalled
- 50 bottles
All recalls from Asclemed USA Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
