ADMELOG Insulin Lispro Recalled for Malformed Seal Defect
Sanofi-Aventis is recalling 51,325 vials of ADMELOG insulin lispro due to defective seals that may compromise sterility. Affected lot: 3F497B, expires 12-31-2025. Contact your pharmacist if you are using this product.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a manufacturing defect (malformed seal) affecting sterility assurance of a critical medication. No illnesses or injuries have been reported. Per the rubric, without reported hospitalizations and with a theoretical hazard in a high-risk product, the severity score is 3 (High).
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling 51,325 vials of ADMELOG (insulin lispro injection), 100 units/mL, in 3mL multi-dose vials. The recall affects lot number 3F497B with an expiration date of 12-31-2025. This product was distributed nationwide in the United States.
The recall was initiated due to a manufacturing defect: malformed crimped collar seals on the vials. These defective seals compromise assurance of sterility for the product. Multi-dose vials are used repeatedly, and a compromised seal could allow bacterial or other contamination to enter the vial during use.
Insulin lispro is a rapid-acting insulin used to treat diabetes. Any contamination of the product could pose a serious health risk to patients who depend on this medication.
Patients currently using insulin from the affected lot should contact their pharmacy or healthcare provider immediately. Do not use vials from lot 3F497B. Ask your pharmacist or doctor about obtaining a replacement supply. No illnesses or adverse events have been reported to date related to this recall.
The recalled product
- Product
- ADMELOG (INSULIN LISPRO)
- Brand
- ADMELOG
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Category
- Drug — Injectable / Insulin
- Hazard
- sterility-assurance-failure
- malformed-seal
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 3F497B
- EXP 12-31-2025
Distribution
Distributed nationwide across the United States.
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