---
title: "TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml ... — FDA record D-0531-2025 | Is It on Recall"
description: "Marketed Without an Approved NDA/ANDA"
url: https://isitonrecall.com/recall/fda-drug-d-0531-2025-testo-200-testosterone-cypionate-inj-usp-2000mg-10ml-200mg-ml-one-10ml-multidose-vial-per-carton-for/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramusc... — FDA record D-0531-2025

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 May 30, 2025. 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**: TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01
- **Reason**: Marketed Without an Approved NDA/ANDA
- **Classification**: Class II
- **Recalling firm**: Advanced Pharmaceutical Technology, Inc.
- **Quantity**: 26 vials
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-0531-2025

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0531-2025%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 P-24-1; Exp. 02/28/2027 |

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

## Distribution

NY, NJ

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

- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)

## Dates in the source

- **Report date**: Jul 2, 2025
- **Recall initiation date**: May 30, 2025
- **Center classification date**: Jul 16, 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.

## 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-0531-2025%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 Pharmaceutical Technology, Inc. records](https://isitonrecall.com/brand/advanced-pharmaceutical-technology-inc/)