Ofloxacin recalls

The FDA has published 5 recalls involving Ofloxacin since 2014. The latest was reported on 25 Jan 2023. Most were for potency & assay. Pack Pharmaceuticals 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 recalls5since 2014

Last 12 months0reported

Class I00% of total

Ongoing1latest 25 Jan 2023

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 0 0%Class II 3 60%Class III 2 40%

Why ofloxacin is recalled

Companies

Pack Pharmaceuticals240%
Akorn120%
Mckesson Medical-Surgical Inc. Corporate Office120%
Altaire Pharmaceuticals120%

Brands

Ofloxacin120%
Ofloxacin Ophthalmic120%

By year

2023120%
2022120%
2019120%
2014240%

Ongoing ofloxacin recalls

1 active

Reported	Class	Recall	Company	Reason	Where
25 Jan 2023Drug	CLASS II	Ofloxacin Ophthalmic Solution recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide

All ofloxacin recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
25 Jan 2023Drug	CLASS II	Ofloxacin Ophthalmic Solution recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	Ofloxacin Otic Solution recalled by Mckesson Medical-SurgicalOfloxacin	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
27 Nov 2019Drug	CLASS II	Ofloxacin Ophthalmic Solution recalled by Altaire PharmaceuticalsOfloxacin Ophthalmic	Altaire Pharmaceuticals	Sterility	Nationwide
12 Feb 2014Drug	CLASS III	Ofloxacin Ophthalmic Solution, USP 0.3% recalled by PACK Pharmaceuticals	Pack Pharmaceuticals	Potency & Assay	Nationwide
12 Feb 2014Drug	CLASS III	Ofloxacin Ophthalmic Solution, USP 0.3% recalled by PACK Pharmaceuticals	Pack Pharmaceuticals	Potency & Assay	Nationwide

Should you stop taking Ofloxacin?

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.