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 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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