HADLIMA Injectable Drug Recalled for Lack of Sterility Assurance
HADLIMA (adalimumab-bwwd) injectable is being recalled due to lack of assurance of sterility. The recall affects 5,518 packs distributed to a single warehouse in New Jersey.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a lack of sterility assurance in an injectable drug, which represents a risk-of-harm product. No illnesses or injuries have been reported, placing this in the High category per the rubric.
Plain-English summary
HADLIMA (adalimumab-bwwd) is a prescription injectable drug supplied as 40mg/0.8 mL prefilled syringes. The FDA has issued a Class II recall for lot F2505017, which expires January 24, 2027.
The recall is due to lack of assurance of sterility. While no illnesses or injuries have been reported, this quality control failure poses a potential risk of microbial contamination.
The recall affects 5,518 packs (11,036 syringes) that were distributed only to a single warehouse in New Jersey. Patients who received HADLIMA from lot F2505017 should not use the medication and should contact their healthcare provider for guidance.
The recalled product
- 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.
- Manufacturer
- Samsung Bioepis Co., Ltd.
- Hazard
- sterility
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: F2505017
- Expiry: 24-Jan-2027
Distribution
Distributed in 1 state:
- NJ
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