Lower riskDrug recall · FDA · Published April 15, 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 risks infection from contaminated product. Patients should contact their doctor for guidance.
“Iso-Tex Volumex Iodinated I 131 Albumin Injection Recall: Sterility Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38904-iso-tex-volumex-iodinated-i-131-albumin-injection-recall-sterility. Based on FDA recall #D-1136-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1136-2019%22&limit=1).
The FDA announced on April 15, 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: V191004-927
Expiration Date: 05/10/19
Quantity: 54 1ml syringes
Distribution: TN
The hazard
The recall is due to an environmental monitoring report exceeding limits, meaning sterility cannot be assured for the product. 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 March 11, 2019, involving Volumex Iodinated I 131 Albumin Injection for sterility risk. Other recent recalls of similar products include Reliance Pemetrexed Injection Recall: Lack of Sterility Risk (June 24, 2026), Reliance Pemetrexed Injection Recall: Sterility Risk in IV Doses (June 24, 2026), and Reliance Bortezomib Injection Recall: Lack of Sterility Risk (June 24, 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'. It was manufactured for Daxor Corp. in New York with NDC 50914-7720-8 and lot number V191004-927.
Brand
Iso-Tex Diagnostics
Category
Drug
Based on the official FDA remedy
What to do — step by step
Contact Your Doctor
Your healthcare provider can advise on next steps for this specific product.
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 20 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-1136-2019 (April 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1136-2019 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.