The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0134-2023·Announced 2023-01-25

Akorn Artificial Tears Eye Drops Recalled for Manufacturing Quality Deviations

Akorn, Inc. is voluntarily recalling 967,075 bottles of Artificial Tears Solution eye drops nationwide due to manufacturing process deviations identified during quality inspections.

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: This is a Class II recall for CGMP deviations with no reported illnesses, injuries, or product defects identified. The recall is voluntary and precautionary in nature, fitting the rubric criterion for 'voluntary precautionary recalls' at the Moderate level.

Plain-English summary

Akorn, Inc. is voluntarily recalling 967,075 bottles of Artificial Tears Solution (Polyvinyl Alcohol 1.4%, 15 mL per bottle) distributed nationwide in the United States. The product was manufactured by Akorn, Inc., Lake Forest, Illinois (NDC 17478-060-12).

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during quality control inspections. CGMP deviations indicate that manufacturing processes did not meet FDA standards for product safety and efficacy. The specific details of these deviations have not been publicly disclosed.

Multiple lot numbers are affected, with expiration dates ranging from October 2022 through August 2023. This is a voluntary recall initiated by the firm.

The recalled product

Product
Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12
Manufacturer
Akorn, Inc.
Category
Drug — Eye Drops
Hazard
Affected units
967,075

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 (20)

  • Lot: 0L44A
  • 0L52A
  • 0L51A
  • 0L77A
  • 0L75A
  • EXP 10/31/2022
  • 0M02A
  • 0M01A
  • EXP 11/30/2022
  • 1C81A
  • EXP 2/28/2023
  • 1D02A
  • 1D03A
  • EXP 3/31/2023
  • 1E10A
  • 1E08A
  • 1E23A
  • 1E26A
  • 1E25A
  • 1E27A

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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