---
title: "HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syr... — FDA record D-0099-2026 | Is It on Recall"
description: "Lack of Assurance of Sterility."
url: https://isitonrecall.com/recall/fda-drug-d-0099-2026-hadlima-adalimumab-bwwd-injection-40mg-0-8-ml-2-single-dose-prefilled-syringes-per-carton-rx-only-ma/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured ... — FDA record D-0099-2026

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 10, 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**: HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.
- **Reason**: Lack of Assurance of Sterility.
- **Classification**: Class II
- **Recalling firm**: Samsung Bioepis Co., Ltd.
- **Quantity**: 5,518 packs (11,036 Syringes) 2 syringes/carton)
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-0099-2026

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0099-2026%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: F2505017, Expiry: 24-Jan-2027 |

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

## Distribution

Distributed only to one warehouse in NJ. with no further distribution

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/)

## Dates in the source

- **Report date**: Nov 5, 2025
- **Recall initiation date**: Oct 10, 2025
- **Center classification date**: Oct 24, 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-0099-2026%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/) [Samsung Bioepis Co., Ltd. records](https://isitonrecall.com/brand/samsung-bioepis-co-ltd/)