Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ketorolac Tromethamine Injection Recalled by Fresenius Kabi USA, LLC Due to Presence of Particulate Matter - found in reserve...
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 Fresenius Kabi USA, LLC directly.
Affected Products
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02
Quantity: 490,633 vials
Why Was This Recalled?
Presence of Particulate Matter - found in reserve sample vials at the firm.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC has 67 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report