Timolol Maleate Ophthalmic Solution USP recall
FDA recall D-0543-2025 · initiated Jul 5, 2025
FDC Limited recalled Timolol Maleate Ophthalmic Solution USP in Jul 2025 — an FDA Class II recall (D-0543-2025) because Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 154,176 bottles
Details
- Product
- Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
- Recalling company
- Fdc Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S Nationwide.
- Initiated
- Jul 5, 2025
- FDA report date
- Aug 6, 2025
Frequently asked
- Was Timolol Maleate Ophthalmic Solution USP recalled?
- FDC Limited recalled Timolol Maleate Ophthalmic Solution USP in Jul 2025 — an FDA Class II recall (D-0543-2025) because Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Timolol Maleate Ophthalmic Solution USP recalled?
- Per the FDA enforcement record, the reason for recall D-0543-2025 was: Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
- Is a recalled Timolol Maleate Ophthalmic Solution USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Timolol Maleate Ophthalmic Solution USP are affected?
- Distributed: U.S Nationwide.. The recall covers these lots — Lot#: 083L061, Exp.: 11/2025.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0543-2025.