Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Ketorolac Tromethamine Injection Recalled by Hikma Pharmaceuticals USA Inc. Due to Presence of Particulate Matter: particles identified as polydimethylsiloxane...
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 Hikma Pharmaceuticals USA Inc. directly.
Affected Products
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
Quantity: 101,710 25 vials/shelf-pack
Why Was This Recalled?
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hikma Pharmaceuticals USA Inc.
Hikma Pharmaceuticals USA Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report