Sanofi Recalls Admelog Insulin Pens Due to Temperature Abuse
Sanofi-Aventis is recalling 3,214 Admelog insulin pens because they may not have been shipped at the proper temperature.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential temperature abuse which may affect product stability, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling 3,214 prefilled pens of Admelog (insulin lispro injection), 100 units/mL (U-100). The product is identified by Lot # 7F021B and an expiration date of 6/30/20. The recall is being conducted because product samples may not have been shipped at the proper temperature.
The recalled product is a prescription-only physician sample that is not for sale. It is distributed nationwide. The specific NDC for the recalled packaging is 0024-5925-00.
Consumers and healthcare providers should stop using the affected pens and contact Sanofi-Aventis or their healthcare provider for further instructions. Do not use the product if it has been exposed to improper temperatures.
The recalled product
- Product
- ADMELOG (INSULIN LISPRO)
- Brand
- ADMELOG
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Category
- Drug — Insulin
- Affected units
- 3,214
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 #: 7F021B
- Exp 6/30/20
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ADMELOG
- HighADMELOG Insulin Lispro Recalled for Malformed Seal Defect
FDA (Drugs) · 2023-05-24
Same manufacturer · Sanofi-Aventis U.S. LLC
See all →- ModerateSanofi Recalls Elitek (Rasburicase) Vials Due to Stability Testing Failures
FDA (Drugs) · 2020-08-26
- SevereSanofi Recalls Zantac Tablets Due to NDMA Impurity
FDA (Drugs) · 2019-12-11
- SevereSanofi Recalls Regular Strength Zantac 75 mg Due to NDMA Impurity
FDA (Drugs) · 2019-12-11
- SevereSanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity
FDA (Drugs) · 2019-12-11
- SevereSanofi Recalls Zantac 75 mg Due to NDMA Impurity
FDA (Drugs) · 2019-12-11
Same hazard · temperature abuse
See all →- SevereKayem Foods Recalls Ready-to-Eat Meat and Poultry Due to Temperature Abuse
USDA FSIS · 2026-10-17
- ModerateZoladex Goserelin Implant Recalled Due to Temperature Abuse
FDA (Drugs) · 2026-10-07
- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateChristopher Ranch peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- ModerateGarland Fresh peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
Similar recalls
- HighADMELOG Insulin Lispro Recalled for Malformed Seal Defect
FDA (Drugs) · 2023-05-24
- SevereNovo Nordisk Recalls Fiasp Insulin Pens Due to Temperature Abuse
FDA (Drugs) · 2021-04-21
- SevereInsulin lispro pens recalled for temperature exposure during distribution
FDA (Drugs) · 2022-05-25
- CriticalNovo Nordisk Recalls Levemir Insulin Pens Due to Temperature Abuse
FDA (Drugs) · 2021-04-21
- SevereNovo Nordisk Recalls Fiasp Insulin Samples Due to Temperature Abuse
FDA (Drugs) · 2021-04-21
- SevereNovo Nordisk Recalls Fiasp Insulin Due to Temperature Abuse
FDA (Drugs) · 2021-04-21