CLASS II Drug recall · Reported 8 May 2019 · FDA Enforcement Report
Revonto (dantrolene sodium for injection), 20 mg/vial recalled
US Worldmeds is recalling Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant, distributed nationwide in the US. The recall was initiated on 25 Apr 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1275-2019
- FDA event ID
- 82660
- Recalling firm
- US Worldmeds, Louisville, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Apr 2019
- FDA classified
- 10 May 2019
- Reported
- 8 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 25 Apr 2019 | Recall initiated by company | |
| 8 May 2019 | Published in enforcement report | +13 days |
| 10 May 2019 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy, Dist. by: US WorldMeds, LLC, Louisville, KY 40241, NDC: 27505-003-67
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Which lots are affected?
Lot: 17REV01, Exp. 12/2019
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Revonto (dantrolene recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Revonto (dantrolene sodium for injection), 20 mg/vial recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |