Class IIOngoing

Ketorolac Tromethamine Injection recall

FDA recall D-0036-2026 · initiated Oct 1, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Presence of Particulate Matter: Particulate matter identified as glass

Details

Product: Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).
Recalling company: Aspiro
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide within the United States
Initiated: Oct 1, 2025
FDA report date: Oct 29, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0036-2026 ↗

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