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.

MethylPREDNISolone Acetate Injectable Suspension Recalled by Sagent Pharmaceuticals Due to Presence of Particulate Matter: Potential for black particulates...

Date: April 25, 2024
Company: Sagent Pharmaceuticals
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 Sagent Pharmaceuticals directly.

Affected Products

MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10

Quantity: 14,360 vials

Why Was This Recalled?

Presence of Particulate Matter: Potential for black particulates in the drug product.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sagent Pharmaceuticals

Sagent Pharmaceuticals has 6 total recalls tracked by RecallDetector.

Related Recalls

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