FDAOctober 10, 2025drug
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Lack of Assurance of Sterility.
What to do
FDA enforcement status: Ongoing
Brands named
samsung bioepissamsung
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCSamsung Recalls Slide-In Electric Ranges Due to Fire Hazard2024-08-08
- FDASoy Bean Sprouts in a package labeled in part: Sam Sung Soy Bean Sprouts, Net Wt. 1LB have a Sell By date of December 21, 2023.2023-12-29
- FDASung Soy Bean Sprouts, 1lb packages, in plastic packages, 20 bags per case2023-12-20
- CPSCSamsung Recalls Top-Load Washing Machines Due to Fire Hazard; Software Repair Available2022-12-22
- CPSCSamsung Recalls Top-Load Washing Machines Due to Risk of Impact Injuries2016-11-04
- CPSCSamsung Expands Recall of Galaxy Note7 Smartphones Based on Additional Incidents with Replacement Phones; Serious Fire and Burn Hazards2016-10-13
- CPSCSamsung Recalls Galaxy Note7 Smartphones Due to Serious Fire and Burn Hazards2016-09-15
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