Pluvicto — Class II drug recall D-0007-2025
Ongoing recall by Advanced Accelerator Applications USA, Inc., reported 2024-10-09, distributed in FL, MA, NJ, NY, PA, VA. CGMP deviations
| Recall number | D-0007-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Accelerator Applications USA, Inc., Millburn, NJ, United States |
| Recall initiated | 2024-09-23 |
| Classified | 2024-10-03 |
| Reported by FDA | 2024-10-09 |
| Distributed | FL, MA, NJ, NY, PA, VA |
| Quantity | 99 doses |
| Reason classes | cgmp |
| NDC | 69488-0010-61 |
| Lot numbers | LPS240919B-16, LPS240920B-16, LPS240920C-16 |
Product
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61
Reason for recall
CGMP deviations
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0007-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.