Direct Rx Duloxetine and Cymbalta Capsules
Duloxetine D/R contains an impurity above the FDA recommended interim limit.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Direct Rx, of Dawsonville, Georgia, recalled Duloxetine D/R due to CGMP Deviations involving the presence of N-nitroso-duloxetine impurity above the FDA recommended interim limit. The recall covers 263 bottles distributed nationwide.
The product was packaged and distributed by Direct Rx under the name CYMBALTA, with strengths of 30 mg in 30 Caps and 60 Caps. The company began the recall on June 22, 2026, and the FDA added it to the Enforcement Report on June 23, 2026.
Summary by Recall Canary from the FDA notice.
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?
Affected if its NDC and lot code are listed under that product.
Duloxetine D/R
- NDC
- 61919-482-30
- 61919-482-60
- Lot
- 09JA2530
- 31JA2507
- 09DE2412
- 09JA2528
- 29JA2511
Details
- Company began the recall
- Sold in
U.S. Nationwide
- Event ID
- 99269
- Recall No.
- D-0617-2026
- Company
- Direct RxDawsonville, Georgia
- Hazard
- Impurity or degradation
- Quantity recalled
- 263 Bottles
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
