The Recall Desk
HighFDA (Drugs)·D-0818-2023·Announced 2023-06-07

Levofloxacin Injection Nationwide Recall Due to Manufacturing Deviations

Akorn, Inc. has recalled all lots of Levofloxacin Injection nationwide due to manufacturing process violations and inability to complete 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 injectable medication with unverified stability due to CGMP deviations and incomplete stability studies. No injuries or illnesses have been reported, but the medication represents a risk of harm if stability has been compromised. The FDA classified this as Class II, and without hospitalization reports, it warrants a High severity rating per the rubric criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Akorn, Inc. is recalling all lots of Levofloxacin Injection 500mg/20 mL (25 mg/mL) for intravenous infusion, available in 20 mL and 30 mL vials. The recall affects the nationwide supply in the United States and Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer went out of business and could no longer continue the stability studies required to ensure the medication maintains its quality and effectiveness over time.

Patients currently using Levofloxacin Injection should contact their healthcare provider regarding this recall.

Healthcare providers and patients should stop using affected lots immediately and consult with their healthcare provider for guidance and alternative treatment options.

The recalled product

Product
Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Intravenous Injection
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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