Recall of Levocarnitine Injection by American Regent
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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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,053 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to May 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.