Adalimumab Recall: HADLIMA injection
Recall involves HADLIMA (adalimumab-bwwd) injection, 40 mg/0.8 mL, 2 single-dose prefilled syringes per carton, Rx only, manufactured for Organon LLC. There are 5,518 packs (11,036 syringes) involved and distribution was limited to one warehouse in New Jersey with no further distribution. Lot F2505017 with expiry 24-Jan-2027 is affected.
| Brand | Samsung Bioepis Co., Ltd. |
|---|---|
| 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. |
| Severity | moderate |
| Units affected | 5518 |
| Distribution | Distributed only to one warehouse in NJ. with no further distribution |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any HADLIMA injection from Lot F2505017.
- Check your supplies and contact your pharmacy or healthcare provider to arrange return, replacement, or disposal.
- For more information, contact Organon or the FDA for guidance.
How to identify the recalled item
| Lot / date codes | Lot: F2505017, Expiry: 24-Jan-2027 |
|---|---|
| Lot / date codes | Lot: F2505017, Expiry: 24-Jan-2027 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.