Recall archive / FDA drug enforcement
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03 — FDA record D-0505-2024
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 May 10, 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 Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Quantity
- 66 bottles of 30 tablets
- Agency-reported status
- Ongoing
- Source record identifier
- D-0505-2024
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 #: J2022G, Exp: 01/01/2025 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product distributed to CA, FL, OK, KS and CT
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
- May 29, 2024
- Recall initiation date
- May 10, 2024
- Center classification date
- May 21, 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.