Arginine recalls

The FDA has published 5 recalls involving Arginine since 2016. The latest was reported on 11 Mar 2020. Most were for sterility. Wells Pharmacy Network 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 2016

Last 12 months0reported

Class I00% of total

Ongoing0latest 11 Mar 2020

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 5 100%Class III 0 0%

Why arginine is recalled

Sterility480%
Packaging Defects120%

Companies

By year

2020120%
2018120%
2017240%
2016120%

All arginine recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
11 Mar 2020Drug	CLASS II	Arginine Hydrochloride Injection recalled by Fusion IV Pharmaceuticals	Fusion IV Pharmaceuticals	Sterility	Nationwide
17 Jan 2018Drug	CLASS II	Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream recalled	KRS Global Biotechnology	Packaging Defects	Nationwide
11 Jan 2017Drug	CLASS II	Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	Arginine HCl 100 mg/mL Injectable recalled by Wells Pharmacy Network	Wells Pharmacy Network	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Arginine 100MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide

Should you stop taking Arginine?

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.