Sanofi-Aventis U.s. Admelog Recall: FDA Class II

Why it was recalled

Lack of Assurance of Sterility: Malformed crimped collar seal

Product description

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

Lot numbers, UPCs & expiration codes

Lot # 3F497B, EXP 12-31-2025

Where it was sold

Nationwide in the USA

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0575-2023
Classification: Class II
Status: Ongoing
Recall initiated: Apr 11, 2023
FDA report date: May 24, 2023
Quantity: 51,325 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Sanofi-Aventis U.S. LLC

Original FDA data

Every field from FDA enforcement report D-0575-2023, exactly as published.

Show all FDA fields

City: Bridgewater
State: NJ
Status: Ongoing
Country: United States
Event ID: 92074
Address: 55 Corporate Dr
Code information: Lot # 3F497B, EXP 12-31-2025
Postal code: 08807-1265
Report date: May 24, 2023
Product type: Drugs
Recall number: D-0575-2023
Classification: Class II
Recalling firm: Sanofi-Aventis U.S. LLC
Product quantity: 51,325 vials
Reason for recall: Lack of Assurance of Sterility: Malformed crimped collar seal
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Nationwide in the USA
Recall initiation date: Apr 11, 2023
Initial firm notification: E-Mail
Center classification date: May 15, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0575-2023, published May 24, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Sanofi-Aventis U.S. Admelog Recall

Summary