FDC Limited recalls 5mL Timolol Maleate Ophthalmic Solution bottles due to cap stuck in nozzle. Rx only. Stop using if you have this product.
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 5mL Timolol Maleate Ophthalmic Solution bottles because the cap can get stuck in the nozzle, making it hard to use the medication. This affects people who need eye drops prescribed by a doctor.
The cap's spike can get lodged in the nozzle, preventing the solution from being dispensed. This means the medication might not work properly if the user can't get the drops out.
People with a prescription for Timolol Maleate eye drops who own the recalled bottles. Those with the specific lot number or expiration date are most at risk.
Check for bottles labeled 'Timolol Maleate Ophthalmic Solution USP 0.5% Sterile 5mL' with lot number 083J033 and expiration date 09/2025. The product is only available by prescription.
Look for the lot number 083J033 and expiration date 09/2025 on the bottle label.
The product is safe to use if the cap can be removed without difficulty. However, if the cap is stuck, it may not dispense the medication properly.
Check for bottles with lot number 083J033 and expiration date 09/2025. The product is only available by prescription.
The recall does not specify a remedy for this issue. Contact your doctor or pharmacist for assistance.
We’ve drafted a message you can send FDC Limited to request your refund or repair — edit it as you like.
Subject: Recall D-0214-2025 — FDC Limited FDC Limited Hello, I own a FDC Limited that is covered by recall D-0214-2025 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.
