Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 64980-0514-01 recalled?

Timolol Maleate · 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE

Yes — this exact package was recalled

2 FDA recalls name the code 64980-0514-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

6 of these recalls are still ongoing.

Active ingredient
timolol maleate
Strength
TIMOLOL MALEATE 5 mg/mL
Form
Solution/ Drops · Ophthalmic
Labeler
Rising Pharma Holdings, Inc.
Type
Human Prescription Drug
Product code
64980-0514

Recalls naming this package

Class II · Moderate risk

Timolol Maleate Ophthalmic Solution USP

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Ongoing Packaging defect FDC Limited NDC 64980-514-01 D-0403-2025
Class II · Moderate risk

Timolol Maleate Ophthalmic Solution USP

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Ongoing Packaging defect FDC Limited NDC 64980-514-05 D-0214-2025
Class II · Moderate risk

Timolol Maleate Ophthalmic Solution USP

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Ongoing Packaging defect FDC Limited NDC 64980-514-05 D-0035-2025
Class II · Moderate risk

Timolol Maleate Ophthalmic Solution USP

Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Ongoing Packaging defect FDC Limited NDC 64980-514-05 D-0642-2024
Class II · Moderate risk

Timolol Maleate Ophthalmic Solution

Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.

Terminated Packaging defect FDC Limited NDC 64980-514-05 D-0488-2024
Class III · Low risk

Timolol Maleate USP

Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.

Terminated Labeling / mix-up Rising Pharmaceuticals, Inc. NDC 64980-514-05 D-1367-2020

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler