Prescription Eye Medication Recalled Due to Defective Cap Design
FDC Limited is recalling approximately 60,428 bottles of Timolol Maleate Ophthalmic Solution USP 0.5% because the cap spike can lodge in the bottle nozzle, preventing patients from dispensing the medication.
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 a Class II FDA recall where patients cannot access their prescribed medication due to a defective container. While no illnesses or injuries have been reported, the inability to dispense the medication represents a risk-of-harm scenario per the rubric criterion for products where injury has not yet been reported.
Plain-English summary
Timolol Maleate Ophthalmic Solution USP 0.5% is a prescription ophthalmic medication. FDC Limited is recalling approximately 60,428 bottles due to a container defect: the spike on the bottle cap can lodge in the bottle nozzle, making it impossible to dispense the medication.
The affected lot is 083I098 with an expiration date of 08/31/2025. The product was distributed nationwide by Rising Pharmaceuticals Inc.
If you have the affected product, contact your pharmacy or healthcare provider for a replacement. Do not attempt to force the cap or modify the bottle.
No illnesses or injuries have been reported in connection with this defect.
The recalled product
- Product
- TIMOLOL MALEATE (TIMOLOL MALEATE)
- Brand
- TIMOLOL MALEATE
- Manufacturer
- FDC Limited
- Category
- Drug — Ophthalmic
- Hazard
- defective-container
- medication-access-obstruction
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 #: 083I098
- Exp. Date 08/31/2025
UPCs (2)
- 0364980513050
- 0364980514057
Distribution
Distributed nationwide across the United States.
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