US Worldmeds Revonto 20mg/vial recall: Precipitate risk in IV use
US Worldmeds recalls Revonto 20mg/vial injections for malignant hyperthermia treatment due to potential precipitate formation in reconstituted solution. This affects specific lots manufactured in Italy.
Lower-risk recall
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Contact the company
What happened, in plain English
US Worldmeds is recalling Revonto (dantrolene sodium for injection) 20 mg/vial products for malignant hyperthermia treatment. The recall is due to a potential precipitate forming in the reconstituted solution after 24 months, which could affect safety during intravenous use. Read more at govinfonow.com/recall/38876-us-worldmeds-revonto-20mg-vial-recall-precipitate-risk-in-iv.
Source Summary by GovInfoNow · govinfonow.com/recall/38876-us-worldmeds-revonto-20mg-vial-recall-precipitate-risk-in-iv · Updated October 5, 2026 · FDA enforcement record: FDA #D-1275-2019
Cite this page
“US Worldmeds Revonto 20mg/vial recall: Precipitate risk in IV use.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38876-us-worldmeds-revonto-20mg-vial-recall-precipitate-risk-in-iv. Based on FDA recall #D-1275-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1275-2019%22&limit=1).
Why it’s dangerous
The product may develop precipitate (solid particles) in the reconstituted solution after 24 months of stability testing. This could potentially cause issues if the medication is administered intravenously, though the exact risk level is not specified in the recall.
Who’s affected
Healthcare professionals who use Revonto for malignant hyperthermia treatment are affected. Patients receiving this medication under medical supervision are at risk if they have the recalled lot.
How to tell if you have this one
Check the product label for 'Revonto (dantrolene sodium for injection), 20 mg/vial'. The lot number 17REV01 with expiration date 12/2019 is affected. This product was manufactured in Italy and distributed by US Worldmeds LLC.
- Brand
US Worldmeds- Category
Drug
What to do — step by step
Check Product Label
Look for the lot number 17REV01 and expiration date 12/2019 on the Revonto vial.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.4 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- 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-1275-2019 (April 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1275-2019 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.