Ophthalmic Eye Drops Recalled for Defective Container Cap Spike
FDC Limited is recalling Timolol Maleate eye drops (0.25%, 15mL bottles) due to a defective cap design where the spike may 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 an FDA Class II recall involving a defective container that prevents patients from accessing their prescribed eye medication. While no illnesses or injuries have been reported, the inability to take timolol for glaucoma management represents a risk-of-harm situation where patients could experience vision loss if the defect goes undetected.
Plain-English summary
FDC Limited is recalling Timolol Maleate Ophthalmic Solution USP 0.25% distributed in 15mL sterile bottles. The recall affects one distributor lot (Lot #083I006, expiration 08/31/2025) consisting of 5,184 bottles that were distributed to one pharmaceutical distributor in New Jersey.
The defect involves the cap design: the spike of the cap can become lodged in the nozzle of the bottle, preventing the solution from being dispensed. This renders the medication inaccessible to patients.
Timolol maleate is a prescription eye medication used to treat glaucoma and elevated intraocular pressure. Patients unable to access their medication due to this defect and who miss doses risk elevated intraocular pressure and potential vision loss.
Patients and healthcare providers who have received bottles from this lot should discontinue use immediately and contact their pharmacy or healthcare provider for replacement medication.
The recalled product
- Product
- TIMOLOL MALEATE (TIMOLOL MALEATE)
- Brand
- TIMOLOL MALEATE
- Manufacturer
- FDC Limited
- Category
- Drug — Ophthalmic
- Hazard
- defective-container
- product-access-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 #: 083I006
- Exp 08/31/2025
UPCs (2)
- 0364980513050
- 0364980514057
Distribution
Distributed in 1 state:
- NJ
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