Recall archive / FDA drug enforcement
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceut... — FDA record D-0580-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 25, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- Classification
- Class II
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
- Quantity
- 1,856 bottles
- Agency-reported status
- Ongoing
- Source record identifier
- D-0580-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot 240539C, Exp 1/31/2027 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
NJ, AZ, IN
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 20, 2025
- Recall initiation date
- Jul 25, 2025
- Center classification date
- Aug 12, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.