July 2025 FDA Recall Timolol Maleate by Fdc Limited
D-0543-2025 - Defective Container
This Class II drug recall was voluntarily initiated by Fdc Limited on July 5, 2025 for the product Timolol Maleate. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0543-2025
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
07-05-2025
08-06-2025
154,176 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
FDC Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
Lot# : 083L061, Exp.: 11/2025.
