Timolol Maleate: 10 recalls on record

Recalled by 1 agency: FDA (10).

First recall on record: July 1, 2020. Most recent: August 6, 2025.

Risk classification: Class II: 8 · Class III: 2

Most recent recalls

DateAgencyProduct
August 6, 2025FDATimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufacture…D-0543-2025
May 14, 2025FDATimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactur…D-0403-2025
February 12, 2025FDATimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufacture…D-0214-2025
December 18, 2024FDATimolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactu…D-0114-2025
November 13, 2024FDATimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufacture…D-0035-2025
August 28, 2024FDATimolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-…D-0642-2024
August 21, 2024FDATimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufacture…D-0632-2024
May 15, 2024FDATimolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514…D-0488-2024
July 1, 2020FDATimolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Applicat…D-1368-2020
July 1, 2020FDATimolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Appli…D-1367-2020

Questions about this brand

How many recalls does Timolol Maleate have?
Recalert has 10 U.S. recalls on record for Timolol Maleate, published between July 1, 2020 and August 6, 2025.
What was the most recent Timolol Maleate recall?
FDA recall D-0543-2025, published August 6, 2025: 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 Jers…
Which agencies have recalled Timolol Maleate products?
Timolol Maleate products appear in recalls from: FDA (10).

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