Leucine recalls

The FDA has published 11 recalls involving Leucine since 2013. The latest was reported on 17 Nov 2021. Most were for sterility. Baxter Healthcare has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls11since 2013
Last 12 months0reported
Class I436% of total
Ongoing0latest 17 Nov 2021

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 4 36%Class II 7 64%Class III 0 0%

Why leucine is recalled

Companies

Brands

By year

All leucine recalls, newest first

11 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IILeucine 10mg/ Isoleucine 15mg/ Valine 40mg/ML recalled by Vita PharmacyVita PharmacySterilityDC, PR
DrugCLASS IILeucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL vial recalledPromise PharmacySterilityNationwide
DrugCLASS II10% Premasol sulfite-free (Amino Acid) Injection recalledPremasol - Sulfite-free (amino Acid)Baxter HealthcareUndeclared SulfitesIL
DrugCLASS IILeucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL recalledWells Pharmacy NetworkSterilityNationwide
DrugCLASS IClinimix E 5/15 sulfite-free (5% Amino Acid recalledClinimix EBaxter HealthcareParticulate MatterNationwide
DrugCLASS IIClinimix E 5/20 sulfite-free (5% amino-acid recalledClinimix EBaxter HealthcareSterilityNationwide
DrugCLASS IIClinimix E 4.25/10 sulfite-free (4.25% Amino Acid recalledClinimix EBaxter HealthcareSterilityNationwide
DrugCLASS IClinimix 4.25/25 sulfite-free (4.25% Amino Acid recalledClinimix EBaxter HealthcareParticulate MatterNationwide
DrugCLASS IClinimix E 4.25/10 sulfite-free (4.25% Amino Acid recalledClinimix EBaxter HealthcareParticulate MatterNationwide
DrugCLASS IClinimix 5/15 sulfite-free (5% Amino Acid recalled by Baxter HealthcareClinimixBaxter HealthcareParticulate MatterNationwide
DrugCLASS II10%, Travasol (Amino Acid) Injection, Pharmacy recalledTravasolBaxter HealthcareSterilityNationwide

Should you stop taking Leucine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.