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 recalls 11 since 2013
Last 12 months 0 reported
Class I 2 18% of total
Ongoing 1 latest 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%
Ongoing amikacin recalls 1 active
All amikacin recalls, newest first 11 total
Reported Class Recall Company Reason Where 22 Feb 2023 Drug CLASS II Amikacin 450MG IN NS, Antibiotic, used in a Homepump recalled Sentara Infusion Services Sterility Nationwide 25 Aug 2021 Drug CLASS II Amikacin Sulfate Injection USP (250mg/ML) single-dose vials recalled Teva Pharmaceuticals USA Sterility Nationwide 19 Jun 2019 Drug CLASS I Amikacin Sulfate Injection, USP (250 mg/ml) vial recalled Amikacin Sulfate Heritage Pharmaceuticals Sterility Nationwide 19 Oct 2016 Drug CLASS II Amikacin Sulfate Injection, USP, 1 gm/ (250 mg/mL) recalled Teva Pharmaceuticals USA Manufacturing (CGMP) Deviations Nationwide 19 Oct 2016 Drug CLASS II Amikacin Sulfate Injection, USP, 500 mg/ (250 mg/mL) recalled Teva Pharmaceuticals USA Manufacturing (CGMP) Deviations Nationwide 1 Jun 2016 Drug CLASS I Amikacin Sulfate injection USP,1 gm/ (250 mg/mL) vial recalled Teva Pharmaceuticals USA Particulate Matter Nationwide 11 Dec 2013 Drug CLASS II Amikacin 500mg, Main Street Compounding Pharmacy recalled Main Street Family Pharmacy Other Nationwide 11 Dec 2013 Drug CLASS II Amikacin 250mg/ml, Main Street Compounding Pharmacy recalled Main Street Family Pharmacy Other Nationwide 11 Dec 2013 Drug CLASS II Amikacin 250mg/ml vial, Main Street Compounding Pharmacy recalled Main Street Family Pharmacy Other Nationwide 17 Jul 2013 Drug CLASS II Amikacin Sulfate 250 mg/ml Injection recalled by Lowlite Investments Lowlite Investments Sterility Nationwide 22 May 2013 Drug CLASS II Amikacin Injection, all strengths and all presentations including recalled FVS Holdings Sterility Nationwide
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.