FDA Recall D-0099-2026

Samsung Bioepis Co., Ltd. · Yeonsu, N/A

Class II Ongoing 216 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot: F2505017, Expiry: 24-Jan-2027

Quantity: 5,518 packs (11,036 Syringes) 2 syringes/carton)

Reason for recall

Lack of Assurance of Sterility.

Recall record

Recall number: D-0099-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed only to one warehouse in NJ. with no further distribution
Recall initiated: 2025-10-10
Classified by FDA Center: 2025-10-24
FDA published: 2025-11-05
Recalling firm: Samsung Bioepis Co., Ltd.
Firm location: Yeonsu, N/A, Korea (the Republic of)

Drug identification

Brand name(s): HADLIMA
Generic name(s): ADALIMUMAB-BWWD
Manufacturer(s): Organon LLC
NDC(s): 78206-184, 78206-183, 78206-185, 78206-186, 78206-187
Route(s): SUBCUTANEOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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