---
title: "Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcuta... — FDA record D-0118-2026 | Is It on Recall"
description: "Lack of Assurance of Sterility"
url: https://isitonrecall.com/recall/fda-drug-d-0118-2026-semaglutide-injection-2-5mg-1ml-2-5-mg-ml-1ml-multidose-vial-for-subcutaneous-use-rx-only-mfd-by-pro/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 J... — FDA record D-0118-2026

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 Oct 15, 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**: Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06
- **Reason**: Lack of Assurance of Sterility
- **Classification**: Class II
- **Recalling firm**: ProRx LLC
- **Quantity**: 2,649 vials
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-0118-2026

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0118-2026%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 Prorx051525-5 |

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

## Distribution

TX and UT

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

- [Texas](https://isitonrecall.com/state/texas/)
- [Utah](https://isitonrecall.com/state/utah/)

## Dates in the source

- **Report date**: Nov 5, 2025
- **Recall initiation date**: Oct 15, 2025
- **Center classification date**: Oct 27, 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-0118-2026%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/) [ProRx LLC records](https://isitonrecall.com/brand/prorx-llc/)