The Recall Desk
ModerateFDA (Drugs)·D-0817-2023·Announced 2023-06-07

Levocarnitine Oral Solution Recalled Due to Incomplete Stability Studies

Akorn, Inc. has recalled all lots of Levocarnitine Oral Solution, USP (118 mL bottles) because the company ceased operations and could not complete required stability studies due to CGMP deviations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II recall with no reported illnesses, injuries, or deaths. The recall is precautionary in nature, initiated because the firm ceased operations and could not complete stability studies rather than due to an identified, manifested health hazard. Per the rubric, voluntary precautionary recalls without reported illness are classified as Moderate (2).

Plain-English summary

Akorn, Inc. has recalled all lots of Levocarnitine Oral Solution, USP, distributed in 118 mL bottles for prescription use. The firm went out of business and was unable to continue required stability studies due to Good Manufacturing Practice (CGMP) deviations.

The affected product was distributed nationwide in the United States and Puerto Rico. All NDC numbers are included in this recall.

Patients currently taking this medication should consult their healthcare provider regarding the recall and any necessary next steps.

The recalled product

Product
Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Prescription Oral Solution
Hazard
  • stability-verification-incomplete

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

Related recalls

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