FDC Limited recalls 0.25% Timolol Maleate Ophthalmic Solution bottles due to cap stuck in nozzle. Stop using if you have the affected lot number.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
FDC Limited is recalling 15mL Timolol Maleate Ophthalmic Solution bottles that have a cap spike lodged in the nozzle, making it impossible to dispense the solution. This defect could lead to improper medication use if the bottle cannot be opened safely.
The cap spike gets stuck in the nozzle, preventing the solution from being dispensed. This could cause the user to not receive the correct dose or risk eye injury from improper handling.
People with a prescription for Timolol Maleate Ophthalmic Solution 0.25% 15mL bottles from FDC Limited (lot 083I006) are affected. Those using the product for eye conditions are most at risk.
Check for bottles labeled 'Timolol Maleate Ophthalmic Solution USP 0.25% Sterile 15mL' with lot number 083I006. The product was distributed by Rising Pharmaceuticals Inc in the US.
Inspect if the cap spike is lodged in the nozzle, making it impossible to dispense the solution.
No, the cap spike can get stuck in the nozzle, preventing proper dispensing of the solution.
Check if the cap spike is lodged in the nozzle; if so, stop using it and contact your doctor.
Look for the lot number 083I006 on the bottle, which was distributed by Rising Pharmaceuticals Inc in the US.
We’ve drafted a message you can send FDC Limited to request your refund or repair — edit it as you like.
Subject: Recall D-0114-2025 — FDC Limited FDC Limited Hello, I own a FDC Limited that is covered by recall D-0114-2025 from FDC Limited. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
