FDC Limited recalls 10mL Timolol Maleate Ophthalmic Solution bottles due to cap stuck in nozzle. Rx only product with lot #083I098 expires 08/31/2025. Stop using if unable to dispense solution.
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 10mL Timolol Maleate Ophthalmic Solution bottles because the cap spike gets stuck in the nozzle, making it impossible to get the solution out. This affects people who need prescription eye drops and could lead to improper medication use.
The cap's spike design gets lodged in the bottle's nozzle, preventing the solution from being dispensed. This means users cannot properly administer their eye drops, potentially leading to incorrect dosing or missed treatments.
Prescription eye drop users who own the recalled Timolol Maleate bottles with lot number 083I098. People with eye conditions requiring regular medication are most at risk.
Check for Timolol Maleate Ophthalmic Solution 10mL bottles with lot number 083I098, manufactured by FDC Limited in Waluj, India, and distributed by Rising Pharmaceuticals Inc. The product expires on 08/31/2025.
Ensure you can dispense the solution by pressing the cap; if stuck, stop using the bottle immediately.
The product is safe if the cap can be dispensed normally. If the cap is stuck in the nozzle, stop using it immediately.
Check if the cap is stuck in the nozzle; if so, stop using it. Contact your doctor for alternative eye drops.
Look for lot number 083I098 on the bottle, manufactured by FDC Limited in Waluj, India, with expiration date 08/31/2025.
We’ve drafted a message you can send FDC Limited to request your refund or repair — edit it as you like.
Subject: Recall D-0403-2025 — FDC Limited FDC Limited Hello, I own a FDC Limited that is covered by recall D-0403-2025 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.
