Drug & Device Safety Atlas

FDA drug recalls · openFDA

Is TIMOLOL MALEATE recalled?

The FDA has recorded 8 recalls of TIMOLOL MALEATE (2024–2025) , recalled under brand like TIMOLOL MALEATE. 7 still ongoing.

0
Class I (most serious)
8
Class II
0
Class III
7
ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of TIMOLOL MALEATE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

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 th 4
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers 1
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the 1
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. 1
Defective container; yellow colored spike from cap lodged in the nozzle 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aura Class II ongoing
FDC Limited 2025-04-18 lots: Lot #: 083I098, Exp. Date 08/31/2025
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Auran Class II ongoing
FDC Limited 2025-07-05 lots: Lot#: 083L061, Exp.: 11/2025.
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Auran Class II ongoing
FDC Limited 2025-01-23 lots: Lot#: 083J033, Exp. Date 09/2025
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC Class II Terminated
FDC Limited 2024-04-25 lots: Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64 Class II ongoing
FDC Limited 2024-08-12 lots: Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Auran Class II ongoing
FDC Limited 2024-10-29 lots: Lot #: 083L051, Exp. Date: 11/2025
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Auran Class II ongoing
FDC Limited 2024-07-18 lots: Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aur Class II ongoing
FDC Limited 2024-12-05 lots: Lot #: 083I006, Exp 08/31/2025

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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