---
title: "Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan in... — FDA record D-0007-2025 | Is It on Recall"
description: "CGMP deviations"
url: https://isitonrecall.com/recall/fda-drug-d-0007-2025-pluvicto-1000-mbq-ml-27-mci-ml-lutetium-lu-177-vipivotide-tetraxetan-injection-single-dose-vial-ster/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manu... — FDA record D-0007-2025

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 Sep 23, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: CGMP deviations
- **Classification**: Class II
- **Recalling firm**: Advanced Accelerator Applications USA, Inc.
- **Quantity**: 99 doses
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-0007-2025

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0007-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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#: LPS240919B-16, 24-Sep-2024 Lot#: LPS240920B-16, 25-Sep-2024 Lot#: LPS240920C-16, 25-Sep-2024 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

FL, MA, NJ, NY, PA, and VA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Florida](https://isitonrecall.com/state/florida/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Virginia](https://isitonrecall.com/state/virginia/)

## Dates in the source

- **Report date**: Oct 9, 2024
- **Recall initiation date**: Sep 23, 2024
- **Center classification date**: Oct 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0007-2025%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Advanced Accelerator Applications USA, Inc. records](https://isitonrecall.com/brand/advanced-accelerator-applications-usa-inc/)