Quick answers
- What is Volumex?
- Volumex is a brand name of Iodinated I-131 albumin, a prescription medicine. The FDA NDC Directory lists 1 Volumex product in 1 strength and form.
- Who makes Volumex?
- Iso Tex holds the FDA application for Volumex (BLA017837, approved February 23, 1976).
- Is there a generic or store brand of Volumex?
- Other products of Iodinated I-131 albumin are listed with the FDA, but none in exactly the same strength and form as a Volumex product.
- Has Volumex been recalled?
- FDA enforcement reports list 2 recalls of Volumex products; the newest started April 15, 2019. A recall usually concerns specific lots, not every product.
What Volumex is
Each Volumex 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.
Iodinated I-131 albumin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| human serum albumin I-131 0.025 mCi/mL injection, solution (intravenous) | Volumex | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Iodinated I-131 albumin →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA017837 | Iso Tex | February 23, 1976 | 1 |
Companies that list Volumex
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Volumex products.
- Iso-Tex Diagnostics, Inc.1 product
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.
-
April 15, 2019 · Class II · Terminated · D-1136-2019
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8. — Iso-Tex Diagnostics, Inc
-
March 11, 2019 · Class II · Terminated · D-1008-2019
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8. — Iso-Tex Diagnostics, Inc
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.