FDA recalls Timolol Maleate eye drops due to defective bottle cap
FDC Limited recalls Timolol Maleate Ophthalmic Solution nationwide because the bottle cap spike becomes lodged in the nozzle, preventing patients from dispensing the medication. No illnesses have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a packaging-only defect that prevents product access. No illnesses or injuries have been reported. The hazard is functional rather than a contamination or safety threat.
Plain-English summary
Timolol Maleate Ophthalmic Solution USP, 0.5%, manufactured by FDC Limited and distributed by Rising Pharmaceuticals Inc, is being recalled nationwide. The affected lots are 083K063 (expiration 10/31/2025) and 083I091 (expiration 08/31/2025), totaling approximately 176,784 bottles in 5mL and 10mL sizes.
The recall was initiated due to a packaging defect. The spike on the bottle cap can become lodged in the nozzle of the product bottle during manufacturing or handling, preventing patients from accessing and dispensing the eye drops.
This medication is used to treat elevated intraocular pressure and glaucoma. Patients who obtained prescriptions from the affected lot numbers should discontinue use and contact their pharmacy or healthcare provider for guidance on obtaining unaffected product or an alternative medication.
The recalled product
- Product
- TIMOLOL MALEATE (TIMOLOL MALEATE)
- Brand
- TIMOLOL MALEATE
- Manufacturer
- FDC Limited
- Category
- Drug — Ophthalmic
- Hazard
- defective-container
- access-defect
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 (4)
- Lot #: a) 083K063
- Exp 10/31/2025
- b) 083I091
- Exp 08/31/2025.
UPCs (2)
- 0364980513050
- 0364980514057
Distribution
Distributed nationwide across the United States.
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