Levocarnitine recalls

The FDA has published 4 recalls involving Levocarnitine since 2014. The latest was reported on 6 May 2026. Most were for labeling errors. John W Hollis 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 recalls4since 2014

Last 12 months1reported

Class I00% of total

Ongoing2latest 6 May 2026

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 1 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 75%Class III 1 25%

Why levocarnitine is recalled

Companies

By year

2026125%
2023125%
2020125%
2014125%

Ongoing levocarnitine recalls

2 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

All levocarnitine recalls, newest first

4 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
11 Mar 2020Drug	CLASS II	Levocarnitine Injection, Levocarnitine 500 MG/ML Injectable recalled	Fusion IV Pharmaceuticals	Foreign Material	Nationwide
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.