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.
What this means for you
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
- stability-data-gap
- cgmp-deviation
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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