The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0142-2023·Announced 2023-01-25

Akorn recalls Levofloxacin eye drops due to manufacturing compliance issues

Akorn, Inc. is recalling Levofloxacin Ophthalmic Solution due to manufacturing process deviations. The voluntary recall affects 3,108 bottles distributed nationwide.

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: Voluntary, precautionary FDA Class II recall for manufacturing process deviations with no reported illnesses or injuries. The absence of demonstrated harm and precautionary nature classify this as Moderate severity.

Plain-English summary

Akorn, Inc. is recalling Levofloxacin Ophthalmic Solution 0.5%, 5 mL bottles. The product is a prescription eye medication (NDC 17478-106-10).

The recall is due to current good manufacturing practice (CGMP) deviations identified in the manufacturing process. This is a voluntary, precautionary recall initiated by the manufacturer.

The affected product was lot #1F43A, expiring 5/31/2023, and was distributed nationwide in the United States. Approximately 3,108 bottles are affected.

Patients currently using this medication should consult their healthcare provider before stopping treatment or switching to an alternative. Healthcare providers should verify whether their supply includes affected lot numbers.

The recalled product

Product
Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic / Eye Drops
Hazard
Affected units
3,108

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 (2)

  • Lot # 1F43A
  • EXP 5/31/2/023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 27 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 27 products in this recall →

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