FDA Drugs recall ·
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles… recall
- Recall number
- D-0403-2025
- Date
- (initiated April 18, 2025)
- Company / brand
- FDC Limited
B-8 MIDC Industrial Area, Aurangabad, Maharashtra State, N/A, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 60428 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
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.
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 #: 083I098, Exp. Date 08/31/2025
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-0403-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.