Recall archive / FDA drug enforcement
Alprostadil Container Description: Amber color bottle — FDA record D-0261-2025
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 Feb 7, 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
- Alprostadil Container Description: Amber color bottle
- Reason
- CGMP Deviations
- Classification
- Class II
- Recalling firm
- Aspen Biopharma Labs Pvt., Ltd.
- Quantity
- 3.0 gm
- Agency-reported status
- Ongoing
- Source record identifier
- D-0261-2025
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 Numbers: HAALC0020922 exp. date AUG-2025 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
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
- Mar 19, 2025
- Recall initiation date
- Feb 7, 2025
- Center classification date
- Mar 9, 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.