Edetate Disodium recalls

The FDA has published 5 recalls involving Edetate Disodium since 2013. The latest was reported on 1 Feb 2023. Most were for sterility. FVS Holdings 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 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 1 Feb 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 5 100%Class III 0 0%

Why edetate disodium is recalled

Sterility5100%

Companies

By year

2023120%
2019120%
2013360%

All edetate disodium recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
1 Feb 2023Drug	CLASS II	Edetate Calcium Disodium 400MG/ML vial) Injectable recalled	Pharmacy Innovations	Sterility	Nationwide
14 Aug 2019Drug	CLASS II	Edetate Calcium Disodium 150MG/ML Injectable per vial recalled	RXQ Compounding	Sterility	Nationwide
18 Sep 2013Drug	CLASS II	Edetate Disodium 150 MG/ML Injectable, all presentations recalled	Beacon Hill Medical Pharmacy, P.C	Sterility	Nationwide
22 May 2013Drug	CLASS II	Edetate Calcium Disodium Injection, all strengths recalled	FVS Holdings	Sterility	Nationwide
22 May 2013Drug	CLASS II	Edetate Disodium Injection, all strengths recalled by FVS Holdings	FVS Holdings	Sterility	Nationwide

Should you stop taking Edetate Disodium?

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.