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.

FDA recall notice · announced August 6, 2025 · Fdc Limited

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.

Notes

Distribution: U.S Nationwide.
Lot/code information: Lot#: 083L061, Exp.: 11/2025.
Quantity: 154,176 bottles
Status: Ongoing
Products in this recall event:
- 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 Jerse (D-0543-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.