Timolol Maleate Eye Drops Recalled Due to Defective Container
FDC Limited is recalling 155,232 bottles of Timolol Maleate Ophthalmic Solution due to a defective cap spike that becomes lodged in the nozzle, preventing medication dispensing.
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 for a packaging defect that prevents patients from accessing a prescribed medication. While no illnesses or injuries have been reported, the inability to dispense needed eye medication presents a risk of harm, meeting the criterion for High severity.
Plain-English summary
FDC Limited is recalling Timolol Maleate Ophthalmic Solution USP 0.5%, a prescription eye medication supplied in sterile 5 mL bottles. The recall involves 155,232 bottles with lot number 083L051 and expiration date November 2025. The affected bottles were distributed to one wholesaler in New Jersey.
The defect is a manufacturing problem with the bottle and cap. The spike of the cap becomes lodged in the nozzle of the bottle, preventing patients from dispensing the medication. This is a packaging defect that renders the product unusable.
Patients or healthcare providers in possession of affected bottles should contact their pharmacy or the drug manufacturer for further information and instructions.
The recalled product
- Product
- TIMOLOL MALEATE (TIMOLOL MALEATE)
- Brand
- TIMOLOL MALEATE
- Manufacturer
- FDC Limited
- Category
- Drug — Ophthalmic
- Hazard
- defective-container
- medication-access
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 #: 083L051
- Exp. Date: 11/2025
UPCs (2)
- 0364980513050
- 0364980514057
Distribution
Distributed in 1 state:
- NJ
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