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.

Admelog Recalled by Sanofi-Aventis U.S. LLC Due to Lack of Assurance of Sterility: Malformed crimped collar...

Date: April 11, 2023
Company: Sanofi-Aventis U.S. LLC
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 Sanofi-Aventis U.S. LLC directly.

Affected Products

Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05

Quantity: 51,325 vials

Why Was This Recalled?

Lack of Assurance of Sterility: Malformed crimped collar seal

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sanofi-Aventis U.S. LLC

Sanofi-Aventis U.S. LLC has 22 total recalls tracked by RecallDetector.

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