Timolol Maleate ophthalmic solution recalled for defective container cap nozzle
FDC Limited is recalling Timolol Maleate Ophthalmic Solution 0.5% distributed in New Jersey due to defective bottle caps with yellow spikes that can lodge in the nozzle, posing a risk of eye injury.
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 container defect on an ophthalmic medication. No hospitalizations or injuries have been explicitly reported in the source. The defect—a spike lodged in the nozzle—creates a risk of harm to the eye but does not meet the criteria for Severe, which requires reported injuries or hospitalizations for Class II recalls.
Plain-English summary
FDC Limited, through its distributor Rising Pharmaceuticals, Inc., is recalling Timolol Maleate Ophthalmic Solution, USP, 0.5% for a defect in the product container. The defective bottles contain yellow-colored spikes from the cap that can lodge in the nozzle.
The defect was discovered after the firm received several customer complaints. A spike lodged in the nozzle could interfere with proper medication delivery and poses a risk of eye injury if the spike contacts the eye during use.
The recall affects 382,104 units distributed exclusively in New Jersey. The affected lot numbers are: 5mL bottles (Lot #083H008 exp. 07/2025, Lot #083G003 exp. 06/2025, Lot #083J017 exp. 09/2025) and 15mL bottles (Lot #083I013 exp. 08/2025).
Patients currently using this product should discontinue use and contact their healthcare provider or pharmacist. Consumers who have the affected product should return it to the pharmacy where it was dispensed.
The recalled product
- Product
- TIMOLOL MALEATE (TIMOLOL MALEATE)
- Brand
- TIMOLOL MALEATE
- Manufacturer
- FDC Limited
- Category
- Drug — Ophthalmic
- Hazard
- container-defect
- foreign-object
- eye-injury
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 (8)
- Lot #: a) 083H008
- Exp. Date 07/2025
- 083G003
- Exp. Date 06/2025
- 083J017
- Exp. Date 09/2025
- b) 083I013
- Exp. Date 08/2025.
UPCs (2)
- 0364980513050
- 0364980514057
Distribution
Distribution scope not specified by the agency.
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