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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Admelog Insulin Lispro Injection Recalled for Sterility Concerns

Agency Publication Date: May 15, 2023
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Summary

Sanofi-Aventis U.S. LLC is recalling 51,325 vials of Admelog (insulin lispro injection), 100 units/mL (U-100), in 3mL multi-dose vials. The recall was issued because some vials have a malformed crimped collar seal, which means the sterility of the injectable medication cannot be guaranteed. If you use this medication, you should consult with your doctor or pharmacist to determine if your supply is affected and how to obtain a safe replacement.

Risk

A malformed seal may allow bacteria or other contaminants to enter the vial. Injecting a contaminated medication poses a significant risk of serious infection or other medical complications.

What You Should Do

  1. This recall affects Admelog (insulin lispro injection) 100 units/mL (U-100) in 3mL multi-dose vials (NDC 0024-5926-05).
  2. Identify affected products by looking for lot number 3F497B with an expiration date of 12-31-2025 printed on the vial or carton.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Sanofi-Aventis U.S. LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Admelog, insulin lispro injection, 100 units/mL (U-100) (3mL)
Variants: 3mL multi-dose vial, 100 units/mL (U-100)
Lot Numbers:
3F497B (Exp 12-31-2025)
NDC:
0024-5926-05

Recall initiated due to malformed crimped collar seal affecting assurance of sterility.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92074
Status: Active
Manufacturer: Sanofi-Aventis U.S. LLC
Sold By: Pharmacies; Hospitals
Manufactured In: United States
Units Affected: 51,325 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.