Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ketorolac Tromethamine Ophthalmic Solution Recalled by Sun Pharma Global Fze Due to Presence of Particulate Matter: lot is not meeting...
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 Sun Pharma Global Fze directly.
Affected Products
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; NDC 41616-219-90, UPC 3 41616 21990 6.
Quantity: 5322 bottles
Why Was This Recalled?
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sun Pharma Global Fze
Sun Pharma Global Fze has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report