Why it was recalled
Lack of Assurance of Sterility.
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.
Lot numbers, UPCs & expiration codes
Lot: F2505017, Expiry: 24-Jan-2027
Where it was sold
Distributed only to one warehouse in NJ. with no further distribution
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0099-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 10, 2025
- FDA report date
- Nov 5, 2025
- Quantity
- 5,518 packs (11,036 Syringes) 2 syringes/carton)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Samsung Bioepis Co., Ltd.
Original FDA data
Every field from FDA enforcement report D-0099-2026, exactly as published.
Show all FDA fields
- City
- Yeonsu
- Status
- Ongoing
- Country
- Korea (the Republic of)
- Event ID
- 97710
- Address
- 76 Songdogyoyuk-Ro
- Code information
- Lot: F2505017, Expiry: 24-Jan-2027
- Report date
- Nov 5, 2025
- Product type
- Drugs
- Recall number
- D-0099-2026
- Classification
- Class II
- Recalling firm
- Samsung Bioepis Co., Ltd.
- Product quantity
- 5,518 packs (11,036 Syringes) 2 syringes/carton)
- Reason for recall
- Lack of Assurance of Sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Distributed only to one warehouse in NJ. with no further distribution
- Recall initiation date
- Oct 10, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 24, 2025