The Recall Desk
Agency classClass IIOur severity: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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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