Gentamicin recalls

The FDA has published 7 recalls involving Gentamicin since 2013. The latest was reported on 25 Jun 2025. Most were for potency & assay. Teligent Pharma 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 recalls7since 2013

Last 12 months0reported

Class I00% of total

Ongoing1latest 25 Jun 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 1 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 7 100%Class III 0 0%

Why gentamicin is recalled

Companies

Brands

Gentamicin229%
Gentamicin Sulfate114%

By year

2025114%
2022343%
2014114%
2013229%

Ongoing gentamicin recalls

1 active

Reported	Class	Recall	Company	Reason	Where
25 Jun 2025Drug	CLASS II	Gentamicin Injection, USP, (Pediatric), 20 mg recalled by Eugia USGentamicin	Eugia US	Potency & Assay	Nationwide

All gentamicin recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
25 Jun 2025Drug	CLASS II	Gentamicin Injection, USP, (Pediatric), 20 mg recalled by Eugia USGentamicin	Eugia US	Potency & Assay	Nationwide
30 Mar 2022Drug	CLASS II	Gentamicin Sulfate Cream recalled by Teligent Pharma	Teligent Pharma	Potency & Assay	Nationwide
30 Mar 2022Drug	CLASS II	Gentamicin Sulfate Cream recalled by Teligent Pharma	Teligent Pharma	Potency & Assay	Nationwide
30 Mar 2022Drug	CLASS II	Gentamicin Sulfate Ointment USP 1%, packaged as a) tube recalled	Teligent Pharma	Potency & Assay	Nationwide
17 Dec 2014Drug	CLASS II	Gentamicin Injection, USP, equivalent to 40 mg/mL recalledGentamicin	Fresenius Kabi USA	Other	Nationwide
17 Jul 2013Drug	CLASS II	Gentamicin Sulfate Injection USP 80 mg/(40 mg/mL as recalled by HospiraGentamicin Sulfate	Hospira	Particulate Matter	Nationwide
22 May 2013Drug	CLASS II	Gentamicin Injection, all strengths recalled by FVS Holdings	FVS Holdings	Sterility	Nationwide

Should you stop taking Gentamicin?

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.