Quick answers
- What is Hadlima?
- Hadlima is a brand name of Adalimumab-atto, a prescription medicine. The FDA NDC Directory lists 9 Hadlima products in 2 strengths and forms.
- Who makes Hadlima?
- Samsung Bioepis Co Ltd holds the FDA application for Hadlima (BLA761059, approved July 23, 2019). 1 other company (repackagers or distributors) also list Hadlima products.
- Is there a generic or store brand of Hadlima?
- Yes. The FDA NDC Directory lists 2 other products with the same active ingredients, strength and form as a Hadlima product. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Hadlima?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 Hadlima strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Hadlima been recalled?
- FDA enforcement reports list 1 recall of Hadlima products; the newest started October 10, 2025. A recall usually concerns specific lots, not every product.
What Hadlima is
Each Hadlima product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Adalimumab-atto · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| adalimumab 40 mg/0.4 mL solution (subcutaneous) | Hadlima | 2 products, 1 company | DailyMed |
| adalimumab 40 mg/0.8 mL solution (subcutaneous) | Hadlima | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Adalimumab-atto →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA761059 | Samsung Bioepis Co Ltd | July 23, 2019 | 9 |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| adalimumab 40 mg/0.4 mL solution | Brand: Hadlima | $1,258.09–$1,259.45 per mL 2 packages, lowest to highest |
| adalimumab 40 mg/0.8 mL solution | Brand: Hadlima | $617.14–$632.97 per mL 2 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list Hadlima
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Hadlima products.
- Organon LLC5 products
- A-S Medication Solutions4 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 10, 2025 · Class II · Ongoing · D-0099-2026
Lack of Assurance of 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 — Samsung Bioepis Co., Ltd.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.