Drug Recalls

0 Class I (most serious) drug recalls reported in the last 30 days.

Medicine, company or reason Severity All classes Class I — most serious Class II Class III Status Any status Ongoing Completed Terminated Reported Last 30 days Last 90 days Last 12 months All on file Show recalls

1 recall

• Class II Ongoing November 5, 2025

  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…

  Reason: Lack of Assurance of Sterility.

  Samsung Bioepis Co., Ltd.

  Lots, distribution and details

  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.

  Lots / codes

  Lot: F2505017, Expiry: 24-Jan-2027

  Distribution

  Distributed only to one warehouse in NJ. with no further distribution

  Quantity

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

  Recall started

  October 10, 2025 (Voluntary: Firm initiated)

  Severity

  Could cause temporary or medically reversible health problems; serious harm is unlikely.

  FDA recall number

  D-0099-2026

Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.

What the recall classes mean

• Class I Most serious: use could cause serious health problems or death.
• Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
• Class III Not likely to cause health problems — for example a labelling or packaging fault.

Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.