Tobramycin recalls

The FDA has published 16 recalls involving Tobramycin since 2012. The latest was reported on 20 Mar 2024. Most were for sterility. Akorn 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 recalls16since 2012

Last 12 months0reported

Class I00% of total

Ongoing6latest 20 Mar 2024

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 15 94%Class III 1 6%

Why tobramycin is recalled

Companies

Akorn425%
Walter's Pharmacy213%
Sentara Enterprises16%
Walgreens Infusion Services16%
Liberty Drug & Surgical16%
Oregon Compounding Centers16%
Franck's Lab16%
Franck's Lab Inc., d.b.a. Franck's Compounding Lab16%

Brands

By year

202416%
2023638%
202216%
2016425%
201516%
2014213%
201216%

Ongoing tobramycin recalls

6 active

Reported	Class	Recall	Company	Reason	Where
23 Aug 2023Drug	CLASS III	Tobramycin Opthalmic Solution recalled by Alembic PharmaceuticalsTobramycin Ophthalmic Solution	Alembic Pharmaceuticals	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Tobramycin Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Tobramycin Inhalation Solution USP, 300 mg/-dose ampules recalled	Akorn	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS II	Tobramycin Ophthalmic Solution, USP, 0.3% per dropper recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide
25 Jan 2023Drug	CLASS II	Tobramycin Ophthalmic Solution recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide
30 Jul 2014Drug	CLASS II	Tobramycin 300 mg/ Syringe (for Neb) recalled by Franck's Lab	Franck's Lab	Sterility	FL

All tobramycin recalls, newest first

16 total

Reported	Class	Recall	Company	Reason	Where
20 Mar 2024Drug	CLASS II	Tobramycin for Injection, USP per Pharmacy recalled by Eugia USTobramycin	Eugia US	Potency & Assay	Nationwide
23 Aug 2023Drug	CLASS III	Tobramycin Opthalmic Solution recalled by Alembic PharmaceuticalsTobramycin Ophthalmic Solution	Alembic Pharmaceuticals	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Tobramycin Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Tobramycin Inhalation Solution USP, 300 mg/-dose ampules recalled	Akorn	Potency & Assay	Nationwide
22 Feb 2023Drug	CLASS II	Tobramycin 660MG IN NS, antibiotic recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide
25 Jan 2023Drug	CLASS II	Tobramycin Ophthalmic Solution, USP, 0.3% per dropper recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide
25 Jan 2023Drug	CLASS II	Tobramycin Ophthalmic Solution recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm recalledTobradex	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
6 Apr 2016Drug	CLASS II	Tobramycin 14 mg/mL Ophth Solution recalled by Walter's Pharmacy	Walter's Pharmacy	Sterility	PA
6 Apr 2016Drug	CLASS II	Tobramycin 15mg/mL Ophth Solution recalled by Walter's Pharmacy	Walter's Pharmacy	Sterility	PA
3 Feb 2016Drug	CLASS II	Tobramycin 120MG recalled by Sentara Enterprises	Sentara Enterprises	Sterility	NC, VA
6 Jan 2016Drug	CLASS II	Tobramycin 620 mg/NS Accuflo recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
2 Sep 2015Drug	CLASS II	Tobramycin 14 mg/mL Ophthalmic Solution recalled	Liberty Drug & Surgical	Sterility	NJ, NY
12 Nov 2014Drug	CLASS II	Tobramycin, 480mg/, solution for irrigation, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
30 Jul 2014Drug	CLASS II	Tobramycin 300 mg/ Syringe (for Neb) recalled by Franck's Lab	Franck's Lab	Sterility	FL
22 Aug 2012Drug	CLASS II	Tobramycin 1.4% (14mg/ML) Ophthalmic recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Tobramycin?

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.