FDA Class II Recall Issued for HADLIMA Injection Over Potential Sterility Issue
Key Clinical Summary
- Product recall: One lot of HADLIMA (adalimumab-bwwd) injection 40mg/0.8 mL recalled due to potential sterility assurance issues.
- Recall scope: 5518 packs (11 036 syringes total); distributed to one warehouse in New Jersey with no further distribution.
- Clinical impact: Class II recall — use of the affected lot could result in temporary or medically reversible adverse health consequences.
Organon LLC, in coordination with Samsung Bioepis Co., Ltd., has voluntarily initiated a Class II recall of HADLIMA (adalimumab-bwwd) injection, 40 mg/0.8 mL. The product, supplied as two single-dose prefilled syringes per carton (NDC 78206-183-01), was manufactured in Incheon, Republic of Korea, by Samsung Bioepis and distributed by Organon LLC, Jersey City, NJ. The recall applies to Lot F2505017, with an expiration date of January 24, 2027.
The US Food and Drug Administration (FDA) classified this as a Class II recall on October 24, 2025, following Organon’s voluntary initiation on October 10, 2025. The recall was prompted by a lack of assurance of sterility, raising potential concerns for contamination that could compromise patient safety. Although no adverse events have been reported to date, compromised sterility may pose infection risks, particularly in immunocompromised patients.
The affected product was distributed only to one warehouse in New Jersey, with no evidence of further distribution. The company notified its consignee via direct letter, and no public press release has been issued. The recall remains ongoing, and the FDA’s Enforcement Report indicates that the firm acted proactively to prevent potential exposure.
HADLIMA (adalimumab-bwwd) is a biosimilar to Humira (adalimumab) and is indicated for the treatment of several autoimmune and inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. As a TNF-alpha inhibitor, it works by reducing inflammation and immune system overactivity associated with these chronic diseases.
Reference
FDA. Enforcement Report. November 5, 2025. Accessed November 5, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm
