Sanofi-Aventis U.S. LLC recalls
Every recall we track for Sanofi-Aventis U.S. LLC — 22 in all, from 2015–2023 — plus the complaints and injury reports the public filed about them. 3 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Sanofi-Aventis U.S. LLC peaked in 2019 (12); 19 since 2017. 11% rated “stop using now”.
All FDA recall records for Sanofi-Aventis U.S. LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 2 | 0 | 3 |
| 2018 | 1 | 0 | 1 | 0 | 2 |
| 2019 | 1 | 0 | 1 | 10 | 12 |
| 2020 | 0 | 0 | 1 | 0 | 1 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 1 | 1 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Sanofi-Aventis U.S. LLC recalls before 2017
Recalls on record by year.
Most common reasons for Sanofi-Aventis U.S. LLC recalls
What to do if you have a recalled Sanofi-Aventis U.S. LLC product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All Sanofi-Aventis U.S. LLC recalls
10 shown- UnratedDrug
Sanofi-Aventis U.S. LLC recalls Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC,
Sanofi recalls Admelog insulin vials with malformed crimped collar seals that could lead to contamination. Affected vials have NDC 0024-5926-05 and lot # 3F497B, expiring Dec 2025.
SanofiApr 11, 2023 - Lower riskDrug
Sanofi-Aventis U.S. LLC recalls Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC
Sanofi recalls Elitek 7.5 mg injection vials due to stability issues detected in routine testing. This may affect patients with certain cancers. Contact Sanofi for details.
SanofiAug 10, 2020 - UnratedDrug
Sanofi-Aventis U.S. LLC recalls Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219,
Sanofi recalls Cool Mint Zantac 150mg tablets due to detected NDMA impurity. Affected products include specific NDC codes and all lots. Consumers should check their product labels and contact Sanofi for details.
SanofiOct 22, 2019 - Lower riskDrug
Sanofi-Aventis U.S. LLC recalls Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per
Sanofi recalls Admelog Solostar insulin pens that may not have been shipped at proper temperature, risking insulin effectiveness. Affected units include specific lot numbers and expiration dates.
SanofiJul 5, 2018 - Stop using nowDrug
Sanofi-Aventis U.S. LLC recalls Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC.,
Sanofi recalls specific Docetaxel injection vials due to potential over-concentration. Patients should contact their doctor for guidance on safe handling.
SanofiApr 27, 2018 - Lower riskDrug
Sanofi-Aventis U.S. LLC recalls Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business
Sanofi recalls 10-count Enoxaparin Sodium injections with a labeling error that may cause incorrect dosing. Affected units have a syringe labeled 150 mg/1.0 mL in a blister pack marked 120 mg/mL.
SanofiDec 5, 2017 - Lower riskDrug
Sanofi-Aventis U.S. LLC recalls Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The
Sanofi recalls Clolar injection vials (20 mg/20 mL) because they lack the correct package insert for brand-name clofarabine. This affects authorized generic products.
SanofiOct 13, 2017 - Use cautionDrug
Sanofi-Aventis U.S. LLC recalls Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg,
Sanofi-Aventis recalls Gaviscon chewable tablets due to high magnesium levels. Check lot numbers and expiration dates for affected bottles.
GavisconJun 12, 2017 - Lower riskDrug
Sanofi-Aventis U.S. LLC recalls Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation
Sanofi recalls Mozobil (plerixafor) 24mg/1.2mL injections due to missing package inserts. This could affect patients using the medication for certain blood disorders.
SanofiSep 1, 2016 - Stop using nowDrug
Sanofi-Aventis U.S. LLC recalls Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02)
Sanofi-Aventis recalls Auvi-Q auto-injectors due to a defective delivery system that may cause inaccurate dosage. Check your lot numbers immediately.
Auvi-QOct 28, 2015
Sanofi-Aventis U.S. LLC recall questions
How many recalls has Sanofi-Aventis U.S. LLC had?
22 recalls from Sanofi-Aventis U.S. LLC are on record with U.S. safety agencies, from 2015–2023.
What is the most recent Sanofi-Aventis U.S. LLC recall?
Sanofi-Aventis U.S. LLC recalls Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC,, dated Apr 11, 2023. Every Sanofi-Aventis U.S. LLC recall is listed on this page, newest first.
Why are Sanofi-Aventis U.S. LLC products recalled?
The most common reasons on record: CGMP Deviations: Presence of NDMA impurity detected in product. (12); Defective Delivery System; potential to have inaccurate dosage delivery (2).
What should I do if I have a recalled Sanofi-Aventis U.S. LLC product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new Sanofi-Aventis U.S. LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.