Akorn Ketorolac Tromethamine Ophthalmic Solution Recall

Why it was recalled

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Product description

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

Lot numbers, UPCs & expiration codes

All Lots

Where it was sold

Nationwide in the USA and Puerto Rico

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0813-2023
Classification: Class II
Status: Ongoing
Recall initiated: Apr 26, 2023
FDA report date: Jun 7, 2023
Quantity: N/A
Recall type: Voluntary: Firm initiated
Recalling firm: Akorn, Inc.

Original FDA data

Every field from FDA enforcement report D-0813-2023, exactly as published.

Show all FDA fields

City: Gurnee
State: IL
Status: Ongoing
Country: United States
Event ID: 91788
Address: 5605 Centerpoint Ct Ste A
Code information: All Lots
Postal code: 60031-5278
Report date: Jun 7, 2023
Product type: Drugs
Recall number: D-0813-2023
Classification: Class II
Recalling firm: Akorn, Inc.
Reason for recall: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Nationwide in the USA and Puerto Rico
Recall initiation date: Apr 26, 2023
Initial firm notification: Letter
Center classification date: Jun 1, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0813-2023, published Jun 7, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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