CLASS II ONGOING Drug recall · Reported 24 May 2023 · FDA Enforcement Report
Admelog, insulin lispro injection/mL (U-100) multi-dose vial recalled
Sanofi-Aventis U.S is recalling Admelog, insulin lispro injection/mL (U-100) multi-dose vial, distributed nationwide in the US. The recall was initiated on 11 Apr 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0575-2023
- FDA event ID
- 92074
- Recalling firm
- Sanofi-Aventis U.S, Bridgewater, NJ
- Brand
- Admelog
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Apr 2023
- FDA classified
- 15 May 2023
- Reported
- 24 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Diabetes Medication
Timeline
| 11 Apr 2023 | Recall initiated by company | |
| 15 May 2023 | Classified by FDA | +34 days |
| 24 May 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Malformed crimped collar seal
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Admelog, insulin lispro injection/mL (U-100) multi-dose vial recalled?
Yes. Sanofi-Aventis U.S recalled Admelog, insulin lispro injection/mL (U-100) multi-dose vial on 11 Apr 2023. The recall is Class II and its status is Ongoing. Recall number D-0575-2023.
Why was it recalled?
Lack of Assurance of Sterility: Malformed crimped collar seal
Which lots are affected?
Lot # 3F497B, EXP 12-31-2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sanofi-Aventis U.S
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Elitek (rasburicase) for injection, 5 mg vial recalledElitek | Sanofi-Aventis U.S | Potency & Assay | Nationwide |
| Drug | CLASS II | Regular Strength Zantac 150 mg recalled by Sanofi-Aventis U.S | Sanofi-Aventis U.S | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Zantac 75 mg recalled by Sanofi-Aventis U.S | Sanofi-Aventis U.S | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Regular Strength Zantac 150 mg recalled by Sanofi-Aventis U.S | Sanofi-Aventis U.S | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Regular Strength Zantac 75 mg recalled by Sanofi-Aventis U.S | Sanofi-Aventis U.S | Nitrosamine Impurity | Nationwide |
Other Insulin Lispro recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterile Diluent, Humalog U-100 (insulin lispro injection) recalledHumalog | Eli Lilly & | Sterility | Nationwide |
| Drug | CLASS I | Humalog KwikPen, Insulin lispro injection, U-100 per mL recalledHumalog | Cardinal Health | Temperature Abuse | NM |
| Drug | CLASS II | Admelog Solostar (insulin lispro injection)/ mL (U-100) injection recalledAdmelog | Sanofi-Aventis U.S | Packaging Defects | Nationwide |