Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

KETOROLAC Tromethamine Inj. Recalled by Hospira Inc. Due to Crystallization; identified as calcium salt of Ketorolac

Date: June 30, 2015
Company: Hospira Inc.
Status: Ongoing
Source: FDA (Drug)

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 Hospira Inc. directly.

Affected Products

KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49

Quantity: 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)

Why Was This Recalled?

Crystallization; identified as calcium salt of Ketorolac

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Hospira Inc.

Hospira Inc. has 245 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report