---
title: "BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102... — FDA record D-0540-2025 | Is It on Recall"
description: "CGMP Deviations; potential temperature excursions due to transit delays"
url: https://isitonrecall.com/recall/fda-drug-d-0540-2025-benlysta-belimumab-for-injection-400-mg-20-ml-vial-rx-only-ndc-49401-102-01-gsk/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK. — FDA record D-0540-2025

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 Apr 21, 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**: BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
- **Reason**: CGMP Deviations; potential temperature excursions due to transit delays
- **Classification**: Class II
- **Recalling firm**: Mckesson Medical-Surgical Inc. Corporate Office
- **Quantity**: 3 Vials
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-0540-2025

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0540-2025%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: YK4W, Expiration date: 4/30/2029 |

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

## Distribution

Within the U.S - OH, VA, FL.

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/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Virginia](https://isitonrecall.com/state/virginia/)

## Dates in the source

- **Report date**: Jul 30, 2025
- **Recall initiation date**: Apr 21, 2025
- **Center classification date**: Jul 21, 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-0540-2025%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/) [Mckesson Medical-Surgical Inc. Corporate Office records](https://isitonrecall.com/brand/mckesson-medical-surgical-inc-corporate-office/)