Lantheus Fludeoxyglucose F 18 Injection Recall: Acetonitrile Impurities Risk
Lantheus recalls Fludeoxyglucose F 18 Injection vials with acetonitrile impurities that could cause harm. Affected vials have specific NDC and lot numbers. Contact for return instructions.
Recall notice
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Contact the company
What happened, in plain English
Lantheus is recalling Fludeoxyglucose F 18 Injection vials due to acetonitrile impurities that may cause harm. This is a prescription-only radiopharmaceutical used in medical imaging. The recall affects specific vial lots with NDC 11994-015-01 and lot FDG170518-01. Read more at govinfonow.com/recall/41617-lantheus-fludeoxyglucose-f-18-injection-recall-acetonitrile-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41617-lantheus-fludeoxyglucose-f-18-injection-recall-acetonitrile-impurities-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0942-2017
Cite this page
“Lantheus Fludeoxyglucose F 18 Injection Recall: Acetonitrile Impurities Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41617-lantheus-fludeoxyglucose-f-18-injection-recall-acetonitrile-impurities-risk. Based on FDA recall #D-0942-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0942-2017%22&limit=1).
Why it’s dangerous
The vials contain acetonitrile impurities that exceed safe levels. Acetonitrile is a toxic solvent that could cause harm if the product is used in medical procedures. This is a prescription-only radiopharmaceutical.
Who’s affected
Prescription patients using this radiopharmaceutical for medical imaging. Healthcare providers who administered the product are most at risk.
How to tell if you have this one
Check for NDC 11994-015-01 and lot number FDG170518-01 on the vial label. The product is a 30 mL multiple-dose vial for prescription use only.
- Brand
Lantheus- Category
Drug
What to do — step by step
Check Vial Label
Look for NDC 11994-015-01 and lot number FDG170518-01 on the vial.
Where it went and when
Where it was distributed
Distributed in Puerto Rico.
FDA distribution: “Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Puerto Rico.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0942-2017 (May 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0942-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.