The Recall Desk
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.

What this means for you

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
  • cgmp-deviation
  • efficacy-risk

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.

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