Hadlima recall: Sterility Concern
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of…
Why was Hadlima recalled?
Lack of Assurance of Sterility.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: F2505017, Expiry: 24-Jan-2027
- 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…
- Recalling firm
- Samsung Bioepis Co., Ltd.
- Quantity
- 5,518 packs (11,036 Syringes) 2 syringes/carton)
- Distribution
- Distributed only to one warehouse in NJ. with no further distribution
- Recall date
- November 5, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)