FDC Limited 2025-08-06 Health serious FDA
Health · FDA · Recall #FDA-D-0543-2025
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,… Recall
Issued August 6, 2025 · FDC Limited
In August 2025, FDC Limited recalled the Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
What you should do
- 1 Stop using Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact FDC Limited to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- FDC Limited
- Category
- Health
- Recall date
- August 6, 2025
- Units affected
- Not reported
- Sold at
- U.S Nationwide.
- Recall number
- FDA-D-0543-2025
- Made in
- India
- Issuing agency
- FDA
In context
- FDC Limited has 7 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.