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; yellow colored spike from cap lodged...
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%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, [NDC 64980-514-05].
Quantity: 362,544 bottles
Why Was This Recalled?
Defective container; yellow colored spike from cap lodged in the nozzle
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