FDA Class II · Drug · July 1, 2026
DULOXETINE D/R recall — Direct Rx
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Official ID D-0617-2026 · Official record ↗
Direct Rx recalls
Recall found. Direct Rx is named in FDA Class II recall D-0617-2026 covering DULOXETINE D/R. Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Identifying details: Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.. Status: Ongoing.
Models with recalls
All Direct Rx recalls
Verify with the official sources:
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
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Compiled from official public-domain government data. Last checked September 7, 2026 at 6:00 AM UTC.