Duloxetine Delayed-Release Capsules
Direct Rx is recalling 30 mg Duloxetine Delayed-Release capsules due to N-nitroso-duloxetine impurity levels exceeding FDA limits.
Contact your healthcare provider or pharmacist to discuss alternative treatment options. Do not stop taking your medication without consulting a medical professional.
Recall at a glance
- Quantity recalled
- 263 Bottles
Why it was recalled
Direct Rx is recalling specific lots of Duloxetine Delayed-Release capsules due to the presence of N-nitroso-duloxetine impurity exceeding the FDA recommended interim limit. This recall affects 30 mg strength capsules in 30-count and 60-count bottles.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
DULOXETINE D/R, a)
- Lot code
- 09JA2530, 31JA2507, 2027, 09DE2412, 09JA2528, 29JA2511
- Strength
- 30 mg
- NDC / UPC
- NDC 61919-482-30, NDC 61919-482-60
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Impurity or Degradation recalls
Editorial summary by Recall Canary · summary updated 2026-06-24 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification