Timolol Maleate Solution/ Drops
FDA Recall NDC 64980-513
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 10 recorded enforcement report(s) associated with Timolol Maleate (NDC 64980-513). A significant event, classified as Class II, was initiated on Jul 05, 2025 by Rising Pharma Holdings, Inc.. The reported reason for this action was: "Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
D-0543-2025D-0403-2025D-0214-2025D-0114-2025D-0035-2025D-0642-2024D-0632-2024D-0488-2024D-1368-2020D-1367-2020
Class II Ongoing
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Jul 05, 2025
Aug 06, 2025
154,176 bottles
Recall Profile & Regulatory Data
Event ID
97219
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
FDC Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S Nationwide.
Product Description
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.
Batch or Lot Expiration Information
Lot# : 083L061, Exp.: 11/2025.
Affected Packages Involved in this Recall
64980-513-05Product
64980-513-01Product
64980-513-15Product
64980-514-05Product
64980-514-01Product
64980-514-15Product
Class II Ongoing
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.
Apr 18, 2025
May 14, 2025
60428 bottles
Recall Profile & Regulatory Data
Event ID
96740
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
FDC Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.
Batch or Lot Expiration Information
Lot# : 083I098, Exp. Date 08/31/2025
Affected Packages Involved in this Recall
64980-513-05Product
64980-513-01Product
64980-513-15Product
64980-514-05Product
64980-514-01Product
64980-514-15Product
Class II Ongoing
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.
Jan 23, 2025
Feb 12, 2025
118104 bottles
Recall Profile & Regulatory Data
Event ID
96196
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
FDC Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed to one (1) Us Distributor in NJ
Product Description
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.
Batch or Lot Expiration Information
Lot# : 083J033, Exp. Date 09/2025
Affected Packages Involved in this Recall
64980-513-05Product
64980-513-01Product
64980-513-15Product
64980-514-05Product
64980-514-01Product
64980-514-15Product
Class II Ongoing
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.
Dec 05, 2024
Dec 18, 2024
5184 bottles
Recall Profile & Regulatory Data
Event ID
95921
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
FDC Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed to one Us Distributor in NJ.
Product Description
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.
Batch or Lot Expiration Information
Lot# : 083I006, Exp 08/31/2025
Affected Packages Involved in this Recall
64980-513-05Product
64980-513-01Product
64980-513-15Product
64980-514-05Product
64980-514-01Product
64980-514-15Product
Class II Ongoing
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
Oct 29, 2024
Nov 13, 2024
155,232 bottles
Recall Profile & Regulatory Data
Event ID
95648
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
FDC Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed to one Us Distributor in NJ.
Product Description
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.
Batch or Lot Expiration Information
Lot# : 083L051, Exp. Date: 11/2025
Affected Packages Involved in this Recall
64980-513-05Product
64980-513-01Product
64980-513-15Product
64980-514-05Product
64980-514-01Product
64980-514-15Product
Class II Ongoing
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Aug 12, 2024
Aug 28, 2024
176,784 bottles
Recall Profile & Regulatory Data
Event ID
95140
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
FDC Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide U.S.A.
Product Description
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey
Batch or Lot Expiration Information
Lot# : a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.
Affected Packages Involved in this Recall
64980-513-05Product
64980-513-01Product
64980-513-15Product
64980-514-05Product
64980-514-01Product
64980-514-15Product
July 2024 Class II Recall: Defective container; yellow colored spike from cap lodged in the nozzle
Recall Number
Class II Ongoing
Defective container; yellow colored spike from cap lodged in the nozzle
Jul 18, 2024
Aug 21, 2024
362,544 bottles
Recall Profile & Regulatory Data
Event ID
94990
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
FDC Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
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].
Batch or Lot Expiration Information
Lot# Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25
Affected Packages Involved in this Recall
64980-513-05Product
64980-513-01Product
64980-513-15Product
64980-514-05Product
64980-514-01Product
64980-514-15Product
Class II Terminated
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Apr 25, 2024
May 15, 2024
382,104 units
Recall Profile & Regulatory Data
Event ID
94466
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
FDC Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
New Jersey Only
Termination Date
May 21, 2026
Product Description
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
Batch or Lot Expiration Information
Lot# : a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.
Affected Packages Involved in this Recall
64980-513-05Product
64980-513-01Product
64980-513-15Product
64980-514-05Product
64980-514-01Product
64980-514-15Product
Class III Terminated
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
Nov 15, 2019
Jul 01, 2020
15,072 bottles
Recall Profile & Regulatory Data
Event ID
85829
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Rising Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Aug 22, 2022
Product Description
Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07863, Manufactured by: FDC Limited B-8, MDC Industrial Area, Waluj, Aurangabad - 431-136 Maharashtra, India, NDC 64980-513-05
Batch or Lot Expiration Information
Lot# 089A016, Exp 12/2020
Affected Packages Involved in this Recall
64980-513-05Product
64980-513-01Product
64980-513-15Product
64980-514-05Product
64980-514-01Product
64980-514-15Product
Class III Terminated
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
Nov 15, 2019
Jul 01, 2020
N/A
Recall Profile & Regulatory Data
Event ID
85829
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Rising Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Aug 22, 2022
Product Description
Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663, Manufactured by: FDC Limited B-8, MIDC Industrial Area, Waluj, Aurangbad - 431 136 Marahastra, India, NDC 64980-514-05
Batch or Lot Expiration Information
Lot# 089A016, Exp 12/31/2020
Affected Packages Involved in this Recall
64980-513-05Product
64980-513-01Product
64980-513-15Product
64980-514-05Product
64980-514-01Product
64980-514-15Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
