---
title: "Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syr... — FDA record D-0220-2026 | Is It on Recall"
description: "Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity."
url: https://isitonrecall.com/recall/fda-drug-d-0220-2026-ganirelix-acetate-injection-250-mcg-0-5ml-single-dose-sterile-prefilled-syringe-27-gauge-by-1-2-need/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, ... — FDA record D-0220-2026

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 Nov 13, 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**: Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01
- **Reason**: Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
- **Classification**: Class II
- **Recalling firm**: Lupin Pharmaceuticals Inc.
- **Quantity**: 32736 vials
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-0220-2026

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0220-2026%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 #: WB00006, Exp 12/31/2026 |

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

## Distribution

FL, MA, MI & OH

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/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Ohio](https://isitonrecall.com/state/ohio/)

## Dates in the source

- **Report date**: Dec 17, 2025
- **Recall initiation date**: Nov 13, 2025
- **Center classification date**: Dec 8, 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-0220-2026%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/) [Lupin Pharmaceuticals Inc. records](https://isitonrecall.com/brand/lupin-pharmaceuticals-inc/)