Levocarnitine recalls

The FDA has published 9 recalls involving Levocarnitine since 2014. The latest was reported on 6 May 2026. Most were for sterility. First Royal Care Co. LLC 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 recalls9since 2014

Last 12 months1reported

Class I00% of total

Ongoing3latest 6 May 2026

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 1May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 8 89%Class III 1 11%

Why levocarnitine is recalled

Companies

By year

2026111%
2023111%
2022111%
2021222%
2020111%
2018111%
2016111%
2014111%

Ongoing levocarnitine recalls

3 active

Reported	Class	Recall	Company	Reason	Where
6 May 2026Drug	CLASS III	Levocarnitine Injection, USP (200 mg/mL) Single-Dose Vial recalledLevocarnitine	American Regent	Labeling Errors	Nationwide
7 Jun 2023Drug	CLASS II	Levocarnitine Oral Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
20 Jul 2022Drug	CLASS II	Levocarnitine 500mg/mL-vial, Refrigerate, Tailor Made Compounding recalled	TMC Acquisition	Sterility	Nationwide

All levocarnitine recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
6 May 2026Drug	CLASS III	Levocarnitine Injection, USP (200 mg/mL) Single-Dose Vial recalledLevocarnitine	American Regent	Labeling Errors	Nationwide
7 Jun 2023Drug	CLASS II	Levocarnitine Oral Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
20 Jul 2022Drug	CLASS II	Levocarnitine 500mg/mL-vial, Refrigerate, Tailor Made Compounding recalled	TMC Acquisition	Sterility	Nationwide
3 Nov 2021Drug	CLASS II	Levocarnitine 100mg/ML Mdv Soln recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	7 states
3 Nov 2021Drug	CLASS II	Levocarnitine 100mg/ML Mdv Soln recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	7 states
11 Mar 2020Drug	CLASS II	Levocarnitine Injection, Levocarnitine 500 MG/ML Injectable recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
7 Nov 2018Drug	CLASS II	Levocarnitine 170 mg/mL Injectable, Pharm D Solutions recalled	Pharm D Solutions	Sterility	Nationwide
15 Jun 2016Drug	CLASS II	Levocarnitine 100mg/ML recalled by Well Care Compounding Pharmacy	Well Care Compounding Pharmacy	Sterility	NV
25 Jun 2014Drug	CLASS II	Levocarnitine Solution for injection, l-Carnitine 50 mg recalled	John W Hollis	Sterility	Nationwide

Should you stop taking Levocarnitine?

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.