Timolol eye drop caps can lodge a spike in the nozzle
Timolol Maleate Ophthalmic Solution USP 0.5% is being recalled because of a defective container: the spike of the cap becomes lodged in the nozzle of the bottle. 154,176 bottles affected.
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: FDA Class II recall for a container closure defect, with no contamination, dosing error or health consequence stated in the source.
Plain-English summary
Timolol Maleate Ophthalmic Solution USP, 0.5%, sterile, 5 mL bottles, prescription only, manufactured by FDC Limited of Aurangabad, India and distributed by Rising Pharmaceuticals Inc of New Jersey, NDC 64980-514-05, is being recalled. The action covers 154,176 bottles.
The stated reason is a defective container: the spike of the cap becomes lodged in the nozzle of the product bottle. The FDA classified the action as Class II. The source does not describe a resulting health consequence.
The affected lot is 083L061, expiring 11/2025. Distribution was nationwide in the US.
Patients holding the affected lot should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by the distributor.
The recalled product
- Product
- TIMOLOL MALEATE (TIMOLOL MALEATE)
- Brand
- TIMOLOL MALEATE
- Manufacturer
- FDC Limited
- Category
- Drug — Ophthalmic solution
- Affected units
- 154,176
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#: 083L061
- Exp.: 11/2025.
UPCs (2)
- 0364980513050
- 0364980514057
Distribution
Distributed nationwide across the United States.
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