Recalling firm
FDC Limited
Product type
Drug
Status
Ongoing
Report date
2025-08-06
Distribution
U.S Nationwide.
Product quantity
154,176 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
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.
Code / lot info
Lot#: 083L061, Exp.: 11/2025.
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.