The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0813-2023·Announced 2023-06-07

Akorn Ketorolac Eye Drops Recalled Due to Manufacturing Quality Deviations

Akorn, Inc. is recalling all lots of Ketorolac Tromethamine Ophthalmic Solution 0.5% because the manufacturer went out of business and cannot complete required stability testing.

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 precautionary recall with no reported illnesses or injuries. The recall stems from a manufacturer's inability to complete required stability testing, representing a theoretical rather than confirmed hazard. Per the rubric, precautionary recalls without reported illnesses are rated Moderate.

Plain-English summary

Akorn, Inc. is recalling all lots of Ketorolac Tromethamine Ophthalmic Solution 0.5%, a prescription eye drop medication used to reduce eye inflammation and pain following eye surgery. The product is packaged in 3 mL, 5 mL, and 10 mL bottles and has been distributed nationwide in the United States and Puerto Rico.

The recall is being issued because Akorn, Inc. went out of business and can no longer conduct the stability studies required by FDA good manufacturing practice (CGMP) regulations. Stability testing ensures that a medication remains safe and effective throughout its approved shelf life. The firm's inability to complete these studies means the safety and efficacy of the product can no longer be verified.

Patients who are currently taking this eye drop should contact their healthcare provider or pharmacy to discuss alternative treatments. Healthcare facilities should stop dispensing this product and remove existing inventory from use.

The recalled product

Product
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic Solution
Hazard

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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 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 86 products in this recall →

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