The Recall Desk
ModerateFDA (Drugs)·D-0154-2023·Announced 2023-01-25

Drug recall: Proparacaine eye solution due to manufacturing deviations

Akorn, Inc. is recalling Proparacaine Hydrochloride Ophthalmic Solution due to manufacturing process deviations. The voluntary recall affects 23,026 bottles distributed nationwide.

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: This is an FDA Class II voluntary recall for manufacturing process deviations with no reported illnesses or injuries. Per the severity rubric, voluntary precautionary recalls are classified as Moderate (score 2).

Plain-English summary

Akorn, Inc. is recalling Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL bottles, due to Current Good Manufacturing Practice (CGMP) deviations in the manufacturing process. The affected lot numbers are 0L53A (expiring 10/31/2022) and 1J49A (expiring 8/31/2023). A total of 23,026 bottles have been distributed nationwide in the United States.

This is a voluntary recall initiated by Akorn, Inc. on October 13, 2022, and classified as Class II by the FDA on January 13, 2023. No illnesses or injuries have been reported in connection with this recall.

Consumers and healthcare providers who have this product should discontinue use. For questions or to report adverse events, contact Akorn, Inc. or the FDA.

The recalled product

Product
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic / Eye drops
Hazard
Affected units
23,026

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 (4)

  • Lot: 0L53A
  • EXP 10/31/2022
  • 1J49A
  • EXP 8/31/2023

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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