Recall record at a glance
| Official record | D-0099-2026 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Samsung Bioepis Co., Ltd. |
| Report date | Nov 5, 2025 |
| Recall initiation date | Oct 10, 2025 |
| Quantity | 5,518 packs (11,036 Syringes) 2 syringes/carton) |
| Location | Yeonsu, N/A, Korea (the Republic of) |
Official product description
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.
Why the product was recalled
Lack of Assurance of Sterility.
Distribution information
Distributed only to one warehouse in NJ. with no further distribution
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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