FDA Drugs recall ·
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles… recall
- Recall number
- D-0543-2025
- Date
- (initiated July 5, 2025)
- Company / brand
- FDC Limited
B-8 MIDC Industrial Area, Aurangabad, Maharashtra State, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 154,176 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: 083L061, Exp.: 11/2025.
Distribution
U.S Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0543-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.