Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Timolol Maleate Ophthalmic Solution Recalled by FDC Limited Due to Defective Container: yellow-colored spike from cap lodged in...
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 bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
Quantity: 382,104 units
Why Was This Recalled?
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Where Was This Sold?
New Jersey Only
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