The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0144-2023·Announced 2023-01-25

Akorn Recalls Moxifloxacin Ophthalmic Solution for CGMP Deviations

Akorn, Inc. is recalling 2,563 bottles of Moxifloxacin Ophthalmic Solution nationwide due to manufacturing deviations. The recall is voluntary and affects lot 1E28A with expiration date 4/30/2023.

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: FDA Class II with no reported illnesses, injuries, or hospitalizations. The recall is voluntary and precautionary, initiated by the manufacturer for manufacturing process (CGMP) deviations without specific disclosed hazard.

Plain-English summary

Akorn, Inc. is voluntarily recalling 2,563 bottles of Moxifloxacin Ophthalmic Solution, USP, 0.5%, distributed nationwide. The recalled product is a prescription eye medication supplied in 3 mL dropper bottles. The affected lot is 1E28A with an expiration date of April 30, 2023. The recall number is D-0144-2023.

The recall was initiated due to manufacturing deviations that did not comply with Current Good Manufacturing Practice (CGMP) requirements. No illnesses or injuries have been reported in connection with this recall.

Patients using this medication should not stop taking it without consulting their healthcare provider. Patients with affected lot numbers should contact their pharmacist or healthcare provider for replacement product or further guidance. The pharmacy or healthcare provider can verify the lot number on the prescription bottle.

The recalled product

Product
Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
2,563

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 (3)

  • Lot
  • Expiry: Lots 1E28A
  • exp 4/30/2023

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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