FDC Limited recalls Timolol Maleate Ophthalmic Solution 0.5% bottles where cap spike is lodged in nozzle, preventing solution use. Rx only, distributed by Rising Pharmaceuticals.
Defective Container: patients are 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 Timolol Maleate Ophthalmic Solution 0.5% bottles because the cap spike gets stuck in the nozzle, making it impossible to get the solution out. This could lead to patients not being able to use their eye drops properly.
The cap spike gets stuck in the nozzle of the bottle, so patients cannot properly remove the solution. This means they might not be able to use their eye drops as directed, which could affect their eye health.
People with prescriptions for Timolol Maleate Ophthalmic Solution 0.5% from FDC Limited, specifically those with 5mL or 10mL bottles (NDC 64980-514-05 or 64980-514-01). Patients who need to use the eye drops regularly are most at risk.
Check for 5mL bottles (NDC 64980-514-05) or 10mL bottles (NDC 64980-514-01) with lot numbers 083K063 (expiring 10/31/2025) or 083I091 (expiring 08/31/2025). These are prescription-only eye drops manufactured by FDC Limited in India.
Look for the cap spike stuck in the nozzle to confirm the defective bottle.
No, the cap spike gets stuck in the nozzle, making it impossible to get the solution out. Do not use these bottles.
Check if the cap spike is stuck in the nozzle. If so, stop using it and contact your doctor for alternatives.
Look for 5mL bottles (NDC 64980-514-05) or 10mL bottles (NDC 64980-514-01) with lot numbers 083K063 (expiring 10/31/2025) or 083I091 (expiring 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-0642-2024 — FDC Limited FDC Limited Hello, I own a FDC Limited that is covered by recall D-0642-2024 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.
