Timolol Maleate eye drops recalled for defective dropper cap
FDC Limited is recalling Timolol Maleate ophthalmic solution because the dropper cap spike may become lodged in the bottle nozzle, preventing access to the medication. The recall affects one lot distributed to a single U.S. distributor in New Jersey.
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 defective container recall with no reported illnesses or injuries. The packaging defect prevents product access but poses no inherent safety risk to the medication itself.
Plain-English summary
FDC Limited is recalling Timolol Maleate Ophthalmic Solution USP, 0.5%, due to a defective container. The spike of the dropper cap may become lodged in the bottle nozzle, making it impossible to dispense the medication.
The affected product consists of 118,104 bottles with lot number 083J033 and an expiration date of September 2025. The product was distributed to one U.S. distributor located in New Jersey.
Patients and healthcare providers who have this product should stop using it and contact their healthcare provider or pharmacist for replacement medication. No adverse events have been reported to date.
The recalled product
- Product
- TIMOLOL MALEATE (TIMOLOL MALEATE)
- Brand
- TIMOLOL MALEATE
- Manufacturer
- FDC Limited
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 118,104
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#: 083J033
- Exp. Date 09/2025
UPCs (2)
- 0364980513050
- 0364980514057
Distribution
Distributed in 1 state:
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