Timolol Maleate Ophthalmic Solution USP recall
FDA recall D-0632-2024 · initiated Jul 18, 2024
FDC Limited recalled Timolol Maleate Ophthalmic Solution USP in Jul 2024 — an FDA Class II recall (D-0632-2024) because Defective container; yellow colored spike from cap lodged in the nozzle.
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
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: 362,544 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
- Nationwide in the US
- Initiated
- Jul 18, 2024
- FDA report date
- Aug 21, 2024
Frequently asked
- Was Timolol Maleate Ophthalmic Solution USP recalled?
- FDC Limited recalled Timolol Maleate Ophthalmic Solution USP in Jul 2024 — an FDA Class II recall (D-0632-2024) because Defective container; yellow colored spike from cap lodged in the nozzle. 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-0632-2024 was: Defective container; yellow colored spike from cap lodged in the nozzle
- 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: Nationwide in the US. The recall covers these lots — Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25. 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-0632-2024.