Adalimumab prefilled syringes recalled for lack of sterility assurance
Samsung Bioepis is recalling 5,518 cartons, 11,036 prefilled syringes, of HADLIMA (adalimumab-bwwd) injection 40mg/0.8 mL from one lot for lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: a loss of sterility assurance in an injectable creates an infection risk, and no injuries are reported.
Plain-English summary
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, supplied as two single-dose prefilled syringes per carton, manufactured by Samsung Bioepis of Incheon, Republic of Korea for Organon LLC of Jersey City, New Jersey, is being recalled for lack of assurance of sterility.
The recall covers 5,518 packs, totalling 11,036 syringes, from lot F2505017, expiring 24 January 2027. The record states the product was distributed only to one warehouse in New Jersey, with no further distribution. The FDA has classified the recall as Class II.
Sterility matters for an injectable because the product is administered directly into the body. The enforcement record describes a loss of sterility assurance rather than confirmed contamination, and reports no injuries.
Anyone holding the affected lot should follow the firm's instructions.
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.
- Category
- Drug — Biologic injectable
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:
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