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Drug FDA Class II Ongoing Contamination / non-sterility

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.

Samsung Bioepis Co., Ltd. Published Nov 5, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Samsung Bioepis Co., Ltd. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility.

Hazards

Lack of Sterility Assurance · primary

Affected products (1)

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.

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

Lot codes: F2505017
Code info: Lot: F2505017, Expiry: 24-Jan-2027

Affected areas

New Jersey

Timeline

  1. Initiated
    Oct 10, 2025
  2. Published
    Nov 5, 2025
Recall number
D-0099-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.