The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0133-2023·Announced 2023-01-25

Drug Recall: Artificial Tears Eye Ointment Due to Manufacturing Deviations

Akorn, Inc. is recalling Artificial Tears Ointment (1.16 million tubes nationwide) due to manufacturing practice deviations. The firm voluntarily initiated this recall.

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 3/5 (High).

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 FDA Class II recall for CGMP deviations affecting a sterile eye ointment—a risk-of-harm product where manufacturing deviations may compromise the sterility assurance critical for safe ophthalmic use.

Plain-English summary

Akorn, Inc. is recalling Artificial Tears Ointment, a sterile lubricant eye ointment, due to manufacturing process deviations. Approximately 1,164,171 tubes with various expiration dates from 2022 through 2024 were distributed nationwide.

The recall was initiated after the manufacturer discovered deviations from Current Good Manufacturing Practice (CGMP) standards. These deviations may affect the product's sterility and quality assurance.

The affected product was distributed nationwide in the United States. Consumers using the recalled product should discontinue use and consult their healthcare provider with any health concerns. The FDA maintains a complete list of affected lot numbers and expiration dates.

The recalled product

Product
Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic / Eye Ointment
Hazard
Affected units
1,164,171

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 # 0A08B
  • EXP 12/31/2022
  • 0B63A
  • EXP 1/31/2023
  • 0C72A
  • EXP 2/28/2023
  • 0D14A
  • 0D19A
  • EXP 3/31/2023
  • 0F54A
  • EXP 5/31/2023
  • 0G80B
  • 0G09B
  • 0G97A
  • EXP 6/30/2023
  • 0J78A
  • EXP 8/31/2023
  • 0K23A
  • EXP 9/30/2023
  • 0L64A

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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