The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0819-2023·Announced 2023-06-07

Levofloxacin Oral Solution Recalled Due to Manufacturing Compliance Issues

Akorn, Inc. recalled all lots of Levofloxacin Oral Solution due to the company going out of business and being unable to continue required stability studies. Patients currently taking this medication should contact their healthcare provider.

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: FDA Class II recall with no reported illnesses, injuries, or efficacy failures. The recall is due to a regulatory compliance gap (inability to conduct stability studies) rather than a confirmed safety incident. This is a precautionary recall initiated due to manufacturing documentation requirements.

Plain-English summary

Akorn, Inc. is recalling all lots of Levofloxacin Oral Solution, 25 mg/mL, distributed nationwide in the United States and Puerto Rico. The recall affects all package sizes: 100 mL, 200 mL, and 480 mL bottles.

The recall was initiated because Akorn went out of business and could no longer conduct stability studies required by Current Good Manufacturing Practice (CGMP) regulations. Stability studies are critical for confirming that a drug maintains its stated strength, purity, and safety profile throughout its shelf life.

Patients currently using this medication should contact their healthcare provider or pharmacist to discuss alternative treatments or options for obtaining a replacement prescription. Do not stop taking the medication without consulting a healthcare professional, as an abrupt discontinuation may affect your health condition.

The recalled product

Product
Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug
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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