# FDA recall D-0099-2026

> **Samsung Bioepis Co., Ltd.** · Class II · drug recall initiated 2025-10-10.

## 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 for recall

Lack of Assurance of Sterility.

## Distribution

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

## Key facts

- **Recall number:** D-0099-2026
- **Recalling firm:** Samsung Bioepis Co., Ltd.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-10
- **Report date:** 2025-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Yeonsu, N/A, Korea (the Republic of)

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0099-2026

## Citation

> AI Analytics. FDA recall D-0099-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0099-2026. Source: US FDA. Licensed CC0.

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