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 Sodium Succinate for Injection Recalled by Sagent Pharmaceuticals Inc Due to Failed Impurities/Degradation Specifications: High out of specification results...

Date: March 5, 2018
Company: Sagent Pharmaceuticals Inc
Status: Terminated
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 Inc directly.

Affected Products

methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05.

Quantity: 205,370 vials

Why Was This Recalled?

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sagent Pharmaceuticals Inc

Sagent Pharmaceuticals Inc has 16 total recalls tracked by RecallDetector.

Related Recalls

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