Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Timolol Maleate Ophthalmic Solution USP Recalled by FDC Limited Due to Defective Container: patients are unable to get the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact FDC Limited directly.
Affected Products
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey
Quantity: 176,784 bottles
Why Was This Recalled?
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About FDC Limited
FDC Limited has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report