CLASS II ONGOING Drug recall · Reported 5 Nov 2025 · FDA Enforcement Report
Hadlima (adalimumab-bwwd) injection recalled by Samsung Bioepis Co
Samsung Bioepis is recalling Hadlima (adalimumab-bwwd) injection, 40mg/-dose Prefilled Syringes per, distributed in New Jersey. The recall was initiated on 10 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0099-2026
- FDA event ID
- 97710
- Recalling firm
- Samsung Bioepis, Yeonsu, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Oct 2025
- FDA classified
- 24 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Oct 2025 | Recall initiated by company | |
| 24 Oct 2025 | Classified by FDA | +14 days |
| 5 Nov 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Distributed only to one warehouse in NJ. with no further distribution
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility.
Which lots are affected?
Lot: F2505017, Expiry: 24-Jan-2027
Where was it sold?
Distributed only to one warehouse in NJ. with no further distribution
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.