CLASS II ONGOING Drug recall · Reported 18 Jul 2018 · FDA Enforcement Report
Admelog Solostar (insulin lispro injection)/ mL (U-100) injection recalled
Sanofi-Aventis U.S is recalling Admelog Solostar (insulin lispro injection)/ mL (U-100) injection, distributed nationwide in the US. The recall was initiated on 5 Jul 2018 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-0925-2018
- FDA event ID
- 80387
- Recalling firm
- Sanofi-Aventis U.S, Bridgewater, NJ
- Brand
- Admelog
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Jul 2018
- FDA classified
- 16 Jul 2018
- Reported
- 18 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Drug class
- Diabetes Medication
Timeline
| 5 Jul 2018 | Recall initiated by company | |
| 16 Jul 2018 | Classified by FDA | +11 days |
| 18 Jul 2018 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Which lots are affected?
Lot #: 7F021B, Exp 6/30/20
Where was it sold?
Nationwide
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 26 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 | Admelog, insulin lispro injection/mL (U-100) multi-dose vial recalledAdmelog | Sanofi-Aventis U.S | Sterility | Nationwide |
| Drug | CLASS II | Elitek (rasburicase) for injection, 7.5 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 |
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 | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Admelog, insulin lispro injection/mL (U-100) multi-dose vial recalledAdmelog | Sanofi-Aventis U.S | Sterility | Nationwide |
| Drug | CLASS I | Humalog KwikPen, Insulin lispro injection, U-100 per mL recalledHumalog | Cardinal Health | Temperature Abuse | NM |