Recall of Levocarnitine Injection by American Regent

Source: FDA · United States

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American Regent, Inc. is recalling 74,040 vials of Levocarnitine Injection due to missing labels, affecting products distributed nationwide in the United States.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 13, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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Recall of Levocarnitine Injection

What Happened

American Regent, Inc. is recalling Levocarnitine Injection because of missing labels on the packaging, as classified by the FDA as a Class III recall.

Which Products Are Affected

The affected products are Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, with NDC 0517-1045-01. This recall involves 74,040 single-dose vials from lots 24159N0C0 (expiring June 30, 2026) and 25193N0C0 (expiring July 31, 2027). The products were distributed nationwide in the United States.

What You Should Do

Consumers who have the affected lots should contact American Regent, Inc. for instructions on returning the product. The firm's address is 6610 New Albany Rd E, New Albany, OH 43054-8730.

Why This Matters

This recall affects a large quantity of prescription drugs and highlights the importance of accurate labeling to prevent potential medication errors, though it is considered to have a low risk of adverse health consequences.

Source

FDA Recall Notice: D-0494-2026

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
American Regent, Inc. is recalling 74,040 vials of Levocarnitine Injection due to missing labels, affecting products distributed nationwide in the United States.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.