FDA Recalls Timolol Maleate Eye Drops for Defective Container Cap
The FDA is recalling Timolol Maleate Ophthalmic Solution USP 0.5% due to a defect in the container cap where the spike becomes lodged in the bottle nozzle, potentially preventing proper medication dispensing. The affected lot was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a defective container on a prescription eye medication. While no illnesses or injuries have been reported, the defect—where the cap spike becomes lodged in the nozzle—presents a risk of harm by preventing proper medication dispensing, potentially affecting patients dependent on this medication.
Plain-English summary
The FDA is recalling Timolol Maleate Ophthalmic Solution USP, 0.5%, a prescription eye drop medication manufactured by FDC Limited and distributed by Rising Pharmaceuticals Inc. The recalled product was distributed nationwide throughout the United States.
The recall is due to a defective container in which the spike of the cap becomes lodged in the bottle nozzle. This defect can prevent the proper dispensing of the medication from the bottle.
The affected lot is #083L061 with an expiration date of 11/2025 (NDC 64980-514-05). In total, 154,176 bottles of this product have been identified as potentially affected by the container defect.
Consumers who have a bottle of Timolol Maleate from the affected lot should contact their pharmacist or healthcare provider for instructions regarding replacement and proper disposal of the recalled product.
The recalled product
- Product
- TIMOLOL MALEATE (TIMOLOL MALEATE)
- Brand
- TIMOLOL MALEATE
- Manufacturer
- FDC Limited
- Category
- Drug — Ophthalmic medication
- Hazard
- container-defect
- medication-dispensing-failure
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 (2)
- Lot#: 083L061
- Exp.: 11/2025.
UPCs (2)
- 0364980513050
- 0364980514057
Distribution
Distributed nationwide across the United States.
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