Methylene Blue recalls

The FDA has published 2 recalls involving Methylene Blue since 2018. The latest was reported on 15 Oct 2025. Most were for sterility. GenoGenix 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 recalls2since 2018

Last 12 months1reported

Class I00% of total

Ongoing1latest 15 Oct 2025

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why methylene blue is recalled

Sterility2100%

Companies

GenoGenix150%
Guardian Pharmacy Services150%

By year

2025150%
2018150%

Ongoing methylene blue recalls

1 active

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Methylene Blue for Injection, all strengths recalled by GenoGenix	GenoGenix	Sterility	Nationwide

All methylene blue recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Methylene Blue for Injection, all strengths recalled by GenoGenix	GenoGenix	Sterility	Nationwide
15 Aug 2018Drug	CLASS II	Methylene Blue 10 mg/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX

Should you stop taking Methylene Blue?

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.