How serious is this recall?

FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What should someone who has this product do?

Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Check the product against FDA's description (Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01) and recall number D-0494-2026, then follow American Regent, Inc.'s recall instructions.

Has American Regent, Inc. had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for American Regent, Inc. so far. Argus ingests new FDA enforcement records daily.

Recall Record: Class III Recall: LEVOCARNITINE by American Regent, Inc.

At a glance: American Regent, Inc. recalled Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01 on 2026-05-06. FDA classified this action as a Class III recall (recall number D-0494-2026). Reason for recall: Labeling: Missing Label. Recall status: Ongoing. This is a drug-category FDA recall record. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Key facts

Recalling firm	American Regent, Inc.
Manufacturer	American Regent, Inc.
Brand name	LEVOCARNITINE
Product description	Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01
Classification	Class III
Recall number	D-0494-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Labeling: Missing Label

What consumers should do

Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Specifically, check whether the product in your possession matches the description on file with FDA -- Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01 -- and the recall number D-0494-2026. If it matches, stop using or distributing it and contact American Regent, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

What this classification means

FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. In this case, the recalling firm is American Regent, Inc. and the affected product is described in FDA's record as: Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01. FDA's stated reason for the recall is: Labeling: Missing Label. The recall is tracked under FDA recall number D-0494-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

American Regent, Inc.’s FDA history

Argus HQ has recorded 1 total FDA action tied to American Regent, Inc.: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?: FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
What should someone who has this product do?: Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Check the product against FDA's description (Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01) and recall number D-0494-2026, then follow American Regent, Inc.'s recall instructions.
Has American Regent, Inc. had other FDA recalls or enforcement actions?: This is the only FDA action Argus HQ has on file for American Regent, Inc. so far. Argus ingests new FDA enforcement records daily.
What is the FDA recall number for this event?: FDA recall number D-0494-2026.

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Full FDA history for American Regent, Inc.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Recall Record: Class III Recall: LEVOCARNITINE by American Regent, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-american-regent-inc-d-0494-2026

MLA

"Recall Record: Class III Recall: LEVOCARNITINE by American Regent, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-american-regent-inc-d-0494-2026.

Chicago

Argus HQ Research. "Recall Record: Class III Recall: LEVOCARNITINE by American Regent, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-american-regent-inc-d-0494-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_american_regent_inc_d_0494_2026_2026,
  title = {Recall Record: Class III Recall: LEVOCARNITINE by American Regent, Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-american-regent-inc-d-0494-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗