Gentamicin recalls

The FDA has published 27 recalls involving Gentamicin since 2012. The latest was reported on 25 Jun 2025. Most were for sterility. Lowlite Investments 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 recalls27since 2012

Last 12 months0reported

Class I00% of total

Ongoing5latest 25 Jun 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 1 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 27 100%Class III 0 0%

Why gentamicin is recalled

Companies

Lowlite Investments415%
Anderson Compounding Pharmacy415%
Teligent Pharma311%
Oregon Compounding Centers27%
Akorn27%
Lincare27%
Hospira14%
Nora Apothecary and Alternative Therapies14%

Brands

Gentamicin27%
Gentamicin Sulfate14%

By year

202514%
2022311%
202014%
2019622%
2016311%
201527%
2014311%
2013726%
201214%

Ongoing gentamicin recalls

5 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
17 Jul 2013Drug	CLASS II	Gentamicin 80 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Gentamicin 0.3% Injection, compounded by Olympia Pharmacy recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Gentamicin Sulfate 80 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Gentamicin 300 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide

All gentamicin recalls, newest first

27 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 0.1%, packaged as a) tube recalled	Teligent Pharma	Potency & Assay	Nationwide
8 Apr 2020Drug	CLASS II	Gentamicin 80mg/ Irrigation, containers recalled	The Medicine Shoppe Pharmacy	Sterility	FL
24 Apr 2019Drug	CLASS II	Gentamicin 120 mg/ 0.9% Sodium Chloride recalled	Anderson Compounding Pharmacy	Sterility	Nationwide
24 Apr 2019Drug	CLASS II	Gentamicin 240 mg/ Sterile Water for Irrigation Syringe recalled	Anderson Compounding Pharmacy	Sterility	Nationwide
24 Apr 2019Drug	CLASS II	Gentamicin 160 mg/ Sterile Water for Irrigation recalled	Anderson Compounding Pharmacy	Sterility	Nationwide
24 Apr 2019Drug	CLASS II	Gentamicin 250 mg/ Irrigation recalled by Anderson Compounding Pharmacy	Anderson Compounding Pharmacy	Sterility	Nationwide
20 Mar 2019Drug	CLASS II	Gentamicin Sulfate Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
6 Feb 2019Drug	CLASS II	Gentamicin Sulfate Ophthalmic Solution, USP 0.3% dropper recalled	Akorn	Particulate Matter	Nationwide
15 Jun 2016Drug	CLASS II	Gentamicin 15 MG/ML Ophthalmic Solution, Sterile Droppers recalled	Well Care Compounding Pharmacy	Sterility	NV
3 Feb 2016Drug	CLASS II	Gentamicin, Packaged as a) 70MG in Homepumps, b) 80MG recalled	Sentara Enterprises	Sterility	NC, VA
6 Jan 2016Drug	CLASS II	Gentamicin 14.4 mg/sodium chloride 0.9% Prefilled syringe recalled	Walgreens Infusion Services	Sterility	TX
8 Jul 2015Drug	CLASS II	Gentamicin Sulfate, Gentamicin 14.4 mg / NS Syringe, Qty: 7 Syringes recalled	Lincare	Sterility	AR
8 Jul 2015Drug	CLASS II	Gentamicin 14.4 mg / NS Syringe recalled by Lincare	Lincare	Sterility	AR
17 Dec 2014Drug	CLASS II	Gentamicin Injection, USP, equivalent to 40 mg/mL recalledGentamicin	Fresenius Kabi USA	Other	Nationwide
12 Nov 2014Drug	CLASS II	Gentamicin Sulfate, 100mg/, solution for irrigation, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014Drug	CLASS II	Gentamicin Sulfate, 480mg/, solution for irrigation, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
17 Jul 2013Drug	CLASS II	Gentamicin 80 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Gentamicin 0.3% Injection, compounded by Olympia Pharmacy recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Gentamicin Sulfate 80 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Gentamicin 300 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Gentamicin Sulfate Injection USP 80 mg/(40 mg/mL as recalled by HospiraGentamicin Sulfate	Hospira	Particulate Matter	Nationwide
5 Jun 2013Drug	CLASS II	Gentamicin 24mg/ Irrigation, 15x60ml Syr Irrigation, 14 day recalled	Nora Apothecary and Alternative Therapies	Sterility	Nationwide
22 May 2013Drug	CLASS II	Gentamicin Injection, all strengths recalled by FVS Holdings	FVS Holdings	Sterility	Nationwide
22 Aug 2012Drug	CLASS II	Gentamicin 40mg/ML (80mg/ Injectable recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	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.