Recall archive / FDA drug enforcement
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 6800... — FDA record D-0100-2025
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 Nov 14, 2024. 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, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
- Classification
- Class II
- Recalling firm
- Amerisource Health Services LLC
- Quantity
- 23,490 bottles
- Agency-reported status
- Ongoing
- Source record identifier
- D-0100-2025
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 | a) 30 count; Lot, expiry: DT3023019B, DT3023020A, exp 01/31/2025 b) 1000 count; Lot, expiry: DTB23098A, exp 08/31/2025 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
PA, OH, PR
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
- Dec 11, 2024
- Recall initiation date
- Nov 14, 2024
- Center classification date
- Dec 3, 2024
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.