Aspiro Pharma Limited recalls Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx onl…

Recall date

October 1, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0036-2026

FDA classification

Class II

Brand / firm

Aspiro Pharma Limited

Sold / distributed

Nationwide within the United States

Why it was recalled

Presence of Particulate Matter: Particulate matter identified as glass

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).