Amikacin recalls

The FDA has published 6 recalls involving Amikacin since 2013. The latest was reported on 25 Aug 2021. Most were for sterility. Teva Pharmaceuticals U 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 recalls6since 2013

Last 12 months0reported

Class I233% of total

Ongoing0latest 25 Aug 2021

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 33%Class II 4 67%Class III 0 0%

Why amikacin is recalled

Companies

By year

2021117%
2019117%
2016350%
2013117%

All amikacin recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
25 Aug 2021Drug	CLASS II	Amikacin Sulfate Injection USP (250mg/ML) single-dose vials recalled	Teva Pharmaceuticals U	Sterility	Nationwide
19 Jun 2019Drug	CLASS I	Amikacin Sulfate Injection, USP (250 mg/ml) vial recalledAmikacin Sulfate	Heritage Pharmaceuticals	Sterility	Nationwide
19 Oct 2016Drug	CLASS II	Amikacin Sulfate Injection, USP, 1 gm/ (250 mg/mL) recalled	Teva Pharmaceuticals U	Manufacturing (CGMP) Deviations	Nationwide
19 Oct 2016Drug	CLASS II	Amikacin Sulfate Injection, USP, 500 mg/ (250 mg/mL) recalled	Teva Pharmaceuticals U	Manufacturing (CGMP) Deviations	Nationwide
1 Jun 2016Drug	CLASS I	Amikacin Sulfate injection USP,1 gm/ (250 mg/mL) vial recalled	Teva Pharmaceuticals U	Particulate Matter	Nationwide
22 May 2013Drug	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.