Timolol Maleate Ophthalmic Solution recall
FDA recall D-0488-2024 · initiated Apr 25, 2024
FDC Limited recalled Timolol Maleate Ophthalmic Solution in Apr 2024 — an FDA Class II recall (D-0488-2024) because Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
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: 382,104 units
Details
- Product
- Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
- Recalling company
- Fdc Ltd
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- New Jersey Only
- Initiated
- Apr 25, 2024
- FDA report date
- May 15, 2024
Frequently asked
- Was Timolol Maleate Ophthalmic Solution recalled?
- FDC Limited recalled Timolol Maleate Ophthalmic Solution in Apr 2024 — an FDA Class II recall (D-0488-2024) because Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Timolol Maleate Ophthalmic Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0488-2024 was: Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
- Is a recalled Timolol Maleate Ophthalmic Solution 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 are affected?
- Distributed: New Jersey Only. The recall covers these lots — Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.. 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-0488-2024.