Lysine recalls

The FDA has published 3 recalls involving Lysine since 2019. The latest was reported on 15 Oct 2025. Most were for sterility. Fusion IV 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 recalls3since 2019

Last 12 months1reported

Class I00% of total

Ongoing1latest 15 Oct 2025

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 1Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why lysine is recalled

Sterility3100%

Companies

By year

2025133%
2020133%
2019133%

Ongoing lysine recalls

1 active

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Lysine for Injection, all strengths and presentations recalled	GenoGenix	Sterility	Nationwide

All lysine recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Lysine for Injection, all strengths and presentations recalled	GenoGenix	Sterility	Nationwide
11 Mar 2020Drug	CLASS II	Lysine Hydrochloride Injection recalled by Fusion IV Pharmaceuticals	Fusion IV Pharmaceuticals	Sterility	Nationwide
20 Feb 2019Drug	CLASS II	Lysine HCl, 100 mg/mL injection recalled by Promise Pharmacy	Promise Pharmacy	Sterility	Nationwide

Should you stop taking Lysine?

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.