Timolol Maleate Ophthalmic Solution USP recall
FDA recall D-0214-2025 · initiated Jan 23, 2025
FDC Limited recalled Timolol Maleate Ophthalmic Solution USP in Jan 2025 — an FDA Class II recall (D-0214-2025) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
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.
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: 118104 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
- Distributed to one (1) Us Distributor in NJ
- Initiated
- Jan 23, 2025
- FDA report date
- Feb 12, 2025
Frequently asked
- Was Timolol Maleate Ophthalmic Solution USP recalled?
- FDC Limited recalled Timolol Maleate Ophthalmic Solution USP in Jan 2025 — an FDA Class II recall (D-0214-2025) because 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. 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-0214-2025 was: 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.
- 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: Distributed to one (1) Us Distributor in NJ. The recall covers these lots — Lot#: 083J033, Exp. Date 09/2025. 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-0214-2025.