Lower riskDrug recall · FDA · Published March 11, 2019
Iso-Tex Volumex Iodinated I 131 Albumin Injection Recall: Sterility Risk
Iso-Tex Diagnostics recalls Volumex (Iodinated I 131 Albumin) Injection due to lack of sterility assurance. This radioactive injection risks infection if used improperly.
“Iso-Tex Volumex Iodinated I 131 Albumin Injection Recall: Sterility Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39116-iso-tex-volumex-iodinated-i-131-albumin-injection-recall-sterility. Based on FDA recall #D-1008-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1008-2019%22&limit=1).
The FDA announced on March 11, 2019, that Iso-Tex Diagnostics, Inc. is recalling Volumex (Iodinated I 131 Albumin) Injection USP due to a lack of assurance of sterility. The recall affects 54 syringes distributed in Tennessee.
How to tell if you have it
Brand: Iso-Tex Diagnostics
Product: Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe
NDC: 50914-7720-8
Lot: V190603-922
Expiration: 04/05/19
Distribution: Tennessee
The hazard
The recall is due to a preliminary environmental monitoring report exceeding limits, meaning sterility cannot be assured. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Iso-Tex Diagnostics, Inc. has one other recall on record since April 15, 2019, involving Volumex Iodinated I 131 Albumin Injection for sterility risk. Other recent recalls of similar products include Reliance Pemetrexed Injection Recall (June 24, 2026), Reliance Bortezomib Injection Recall (June 24, 2026), and Fresenius Kabi 5% Dextrose Injection Recall (March 11, 2026).
How to tell if you have this one
Check for the product name 'Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe' with NDC 50914-7720-8. The lot number V190603-922 was manufactured for Daxor Corp. in NY.
Brand
Iso-Tex Diagnostics
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the product by checking the NDC code 50914-7720-8 and lot number V190603-922.
Where it went and when
Where it was distributed
Distributed in Tennessee.
Listed by the agency
Not listed
FDA distribution: “TN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Tennessee.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1008-2019 (March 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1008-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.