Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.

Class I - Dangerous

💊 Drugs Recalled: October 13, 2022 Akorn Prescription Drugs Nationwide

What Should You Do?

Check if you have this product:
Lot: (a) 0B50A, 0B69A, EXP 1/31/2023; 0C74A, EXP 2/28/2023; 0D04A, EXP 3/31/2023; 0E37A, EXP 4/30/2023; 0G07A, 0G82A, EXP 6/30/2023; 0H26A, 0H28A, 0H53A, 0H36A, EXP 7/31/2023; 0J64A, 0J58A, 0J66A, EXP 8/31/2023; 0K96A, 0K06A, 0K98A, 0K04A, 0K03A, 0K99A, EXP 9/30/2023; 0L72A, EXP 10/31/2023; 0M81A, 0M85A, 0M80A, 0M84A, 0M82A, 0M83A, EXP 11/30/2023; 1A01A, 1A02A, EXP 12/31/2023; 1B16A, 1B13A, 1B17A, EXP 1/31/2024; 1C51A, EXP 2/29/2024; (b) 0B59A , EXP 1/31/2023;0E49A, EXP 4/30/2023; 0G14A, EXP 6/30/2023; 0H38A, EXP 7/31/2023; 0J84A, EXP 8/31/2023; 0K05A, EXP 9/30/2023; 0L59A, EXP 10/31/2023; 0M86A, 0M87A, EXP 11/30/2023; 1A03A, EXP 12/31/2023; 1B37A, EXP 1/31/2024; 1C63A, EXP 2/29/2024; 1C54A, EXP 2/29/2024; 1D83A, EXP 3/31/2024; (c) 0C82A, EXP 2/28/2023; 0G84A, EXP 6/30/2023; 0H49A, EXP 7/31/2023; 0J77A, EXP 8/31/2023; 0J75A, EXP 8/31/2023; 0L57A, EXP 10/31/2023; 0L74A, EXP 10/31/2023; 0L46A, EXP 10/31/2023; 1G52A, EXP 6/30/2024; 1J52A, EXP 8/31/2024;
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Akorn, Inc.
Reason for Recall:: CGMP Deviations:
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.

Product Codes/Lot Numbers:

Lot: (a) 0B50A, 0B69A, EXP 1/31/2023; 0C74A, EXP 2/28/2023; 0D04A, EXP 3/31/2023; 0E37A, EXP 4/30/2023; 0G07A, 0G82A, EXP 6/30/2023; 0H26A, 0H28A, 0H53A, 0H36A, EXP 7/31/2023; 0J64A, 0J58A, 0J66A, EXP 8/31/2023; 0K96A, 0K06A, 0K98A, 0K04A, 0K03A, 0K99A, EXP 9/30/2023; 0L72A, EXP 10/31/2023; 0M81A, 0M85A, 0M80A, 0M84A, 0M82A, 0M83A, EXP 11/30/2023; 1A01A, 1A02A, EXP 12/31/2023; 1B16A, 1B13A, 1B17A, EXP 1/31/2024; 1C51A, EXP 2/29/2024; (b) 0B59A , EXP 1/31/2023;0E49A, EXP 4/30/2023; 0G14A, EXP 6/30/2023; 0H38A, EXP 7/31/2023; 0J84A, EXP 8/31/2023; 0K05A, EXP 9/30/2023; 0L59A, EXP 10/31/2023; 0M86A, 0M87A, EXP 11/30/2023; 1A03A, EXP 12/31/2023; 1B37A, EXP 1/31/2024; 1C63A, EXP 2/29/2024; 1C54A, EXP 2/29/2024; 1D83A, EXP 3/31/2024; (c) 0C82A, EXP 2/28/2023; 0G84A, EXP 6/30/2023; 0H49A, EXP 7/31/2023; 0J77A, EXP 8/31/2023; 0J75A, EXP 8/31/2023; 0L57A, EXP 10/31/2023; 0L74A, EXP 10/31/2023; 0L46A, EXP 10/31/2023; 1G52A, EXP 6/30/2024; 1J52A, EXP 8/31/2024;