The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0820-2023·Announced 2023-06-07

Levofloxacin Ophthalmic Solution Recalled Due to Manufacturing Practice Deviations

Akorn, Inc. is recalling all lots of Levofloxacin Ophthalmic Solution 0.5% due to manufacturing practice deviations. The firm went out of business and could not continue required stability studies.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving manufacturing practice deviations. The source does not report any illnesses, injuries, or hospitalizations. Per the rubric, FDA Class II without reported harm is scored as High (3), as the hazard is theoretical rather than confirmed.

Plain-English summary

Akorn, Inc. is recalling all lots of Levofloxacin Ophthalmic Solution, 0.5% in 5 mL bottles (Rx only). The product is distributed nationwide in the United States and Puerto Rico.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer went out of business and was unable to continue the stability studies required to ensure product quality and effectiveness over its shelf life.

The recalled product

Product
Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic antibiotic
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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