Amikacin recalls

The FDA has published 11 recalls involving Amikacin since 2013. The latest was reported on 22 Feb 2023. Most were for sterility. Teva Pharmaceuticals USA 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 I218% of total
Ongoing1latest 22 Feb 2023

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 2 18%Class II 9 82%Class III 0 0%

By year

Ongoing amikacin recalls

1 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIAmikacin Sulfate 250 mg/ml Injection recalled by Lowlite InvestmentsLowlite InvestmentsSterilityNationwide

All amikacin recalls, newest first

11 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIAmikacin 450MG IN NS, Antibiotic, used in a Homepump recalledSentara Infusion ServicesSterilityNationwide
DrugCLASS IIAmikacin Sulfate Injection USP (250mg/ML) single-dose vials recalledTeva Pharmaceuticals USASterilityNationwide
DrugCLASS IAmikacin Sulfate Injection, USP (250 mg/ml) vial recalledAmikacin SulfateHeritage PharmaceuticalsSterilityNationwide
DrugCLASS IIAmikacin Sulfate Injection, USP, 1 gm/ (250 mg/mL) recalledTeva Pharmaceuticals USAManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIAmikacin Sulfate Injection, USP, 500 mg/ (250 mg/mL) recalledTeva Pharmaceuticals USAManufacturing (CGMP) DeviationsNationwide
DrugCLASS IAmikacin Sulfate injection USP,1 gm/ (250 mg/mL) vial recalledTeva Pharmaceuticals USAParticulate MatterNationwide
DrugCLASS IIAmikacin 500mg, Main Street Compounding Pharmacy recalledMain Street Family PharmacyOtherNationwide
DrugCLASS IIAmikacin 250mg/ml, Main Street Compounding Pharmacy recalledMain Street Family PharmacyOtherNationwide
DrugCLASS IIAmikacin 250mg/ml vial, Main Street Compounding Pharmacy recalledMain Street Family PharmacyOtherNationwide
DrugCLASS IIAmikacin Sulfate 250 mg/ml Injection recalled by Lowlite InvestmentsLowlite InvestmentsSterilityNationwide
DrugCLASS IIAmikacin Injection, all strengths and all presentations including recalledFVS HoldingsSterilityNationwide

Should you stop taking Amikacin?

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.