Timolol Maleate Ophthalmic Solution Recalled for Defective Container
FDC Limited is recalling Timolol Maleate Ophthalmic Solution 0.5% due to a defective container where the spike of the cap becomes lodged in the bottle nozzle, preventing users from accessing the solution.
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 with no reported illnesses or injuries. The defect is a mechanical issue with the container that prevents product access rather than a contamination or toxicity hazard, placing it in the Moderate category per the rubric.
Plain-English summary
FDC Limited is recalling approximately 60,428 bottles of Timolol Maleate Ophthalmic Solution USP, 0.5%, distributed nationwide. The recall affects lot #083I098 with an expiration date of 08/31/2025, manufactured by FDC Limited in Waluj, Aurangabad, Maharashtra, India, and distributed by Rising Pharmaceuticals Inc. in New Jersey.
The product is being recalled because the spike of the cap can become lodged in the nozzle of the bottle, making it impossible for patients to dispense the solution. This defect affects the product's ability to function as intended.
Patients currently using this product should contact their healthcare provider or pharmacist for a replacement. The product's NDC number is 64980-514-01, and affected individuals can identify the recall lot by number 083I098 on the bottle.
The recalled product
- Product
- TIMOLOL MALEATE (TIMOLOL MALEATE)
- Brand
- TIMOLOL MALEATE
- Manufacturer
- FDC Limited
- Category
- Drug — Ophthalmic Solution
- Affected units
- 60,428
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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