FDC Limited recalls 5mL Timolol Maleate Ophthalmic Solution bottles due to cap getting stuck in the bottle nozzle. Rx only product with specific lot number and expiration date.
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
FDC Limited is recalling 5mL Timol: 0.5% ophthalmic solution bottles because the cap can get stuck in the bottle nozzle. This could cause the medication to leak or be spilled, making it unsafe to use.
The cap of the bottle can become lodged in the nozzle, causing the medication to leak or spill. This could lead to accidental contact with eyes or skin, but the risk is low since the product is used under medical supervision.
People with a prescription for Timolol Maleate Ophthalmic Solution 0.5% 5mL bottles from FDC Limited. Those who use the product without proper handling may be at risk of medication spillage.
Check for 5mL bottles labeled Timolol Maleate Ophthalmic Solution USP 0.5%, manufactured by FDC Limited, with lot number 083L061 and expiration date 11/2025.
Look for the lot number 083L061 and expiration date 11/2025 on the bottle label.
The product is safe to use if the cap does not get stuck in the nozzle. However, the recall is for specific bottles that may have this defect.
The recall does not specify a remedy, so check the product details and contact your doctor or pharmacist for advice.
Check for 5mL bottles labeled Timolol Maleate Ophthalmic Solution USP 0.5%, manufactured by FDC Limited, with lot number 083L061 and expiration date 11/2025.
We’ve drafted a message you can send FDC Limited to request your refund or repair — edit it as you like.
Subject: Recall D-0543-2025 — FDC Limited FDC Limited Hello, I own a FDC Limited that is covered by recall D-0543-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
