Sanofi-Aventis U.S recalls

Sanofi-Aventis U.S has 22 recalls on record with the FDA and USDA, the earliest in 2016 and the latest reported on 24 May 2023. 15 are still ongoing. The most frequent reason is nitrosamine impurity.

Total recalls22since 2016

Last 12 months0reported

Class I29% of total

Ongoing15latest 24 May 2023

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 2 9%Class II 16 73%Class III 4 18%

Why sanofi-aventis u.s is recalled

Product types

Brands

By year

202315%
202015%
20191255%
2018314%
2017314%
201629%

Ongoing sanofi-aventis u.s recalls

15 active

Reported	Class	Recall	Company	Reason	Where
24 May 2023Drug	CLASS II	Admelog, insulin lispro injection/mL (U-100) multi-dose vial recalledAdmelog	Sanofi-Aventis U.S	Sterility	Nationwide
26 Aug 2020Drug	CLASS II	Elitek (rasburicase) for injection, 7.5 mg vial recalledElitek	Sanofi-Aventis U.S	Potency & Assay	Nationwide
11 Dec 2019Drug	CLASS II	Regular Strength Zantac 150 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Zantac 75 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Regular Strength Zantac 150 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Regular Strength Zantac 75 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide

All sanofi-aventis u.s recalls, newest first

22 total

Reported	Class	Recall	Company	Reason	Where
24 May 2023Drug	CLASS II	Admelog, insulin lispro injection/mL (U-100) multi-dose vial recalledAdmelog	Sanofi-Aventis U.S	Sterility	Nationwide
26 Aug 2020Drug	CLASS II	Elitek (rasburicase) for injection, 7.5 mg vial recalledElitek	Sanofi-Aventis U.S	Potency & Assay	Nationwide
11 Dec 2019Drug	CLASS II	Regular Strength Zantac 150 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Zantac 75 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Regular Strength Zantac 150 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Regular Strength Zantac 75 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Cool Mint Maximum Strength Zantac 150 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Maximum Strength Zantac 150 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Maximum Strength Zantac 150 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Regular Strength Zantac 75 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Zantac 150 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Regular Strength Zantac 75 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Regular Strength Zantac 75 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi recalled	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
18 Jul 2018Drug	CLASS II	Admelog Solostar (insulin lispro injection)/ mL (U-100) injection recalledAdmelog	Sanofi-Aventis U.S	Temperature Abuse	Nationwide
9 May 2018Drug	CLASS II	Docetaxel injection concentrate, 20 mg/mL vial recalledDocetaxel	Sanofi-Aventis U.S	Potency & Assay	Nationwide
17 Jan 2018Drug	CLASS III	Enoxaparin Sodium, Injection 120 mg/, pre-filled recalled	Sanofi-Aventis U.S	Packaging Defects	Nationwide
8 Nov 2017Drug	CLASS III	Clofarabine injection, 20 mg/ Single-Use Vial recalled	Sanofi-Aventis U.S	Packaging Defects	Nationwide
5 Jul 2017Drug	CLASS III	Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength recalled	Sanofi-Aventis U.S	Potency & Assay	Nationwide
17 May 2017Drug	CLASS III	Mozobil (plerixafor injection) 24mg/ (20mg/mL), For Single Use Only recalledMozobil	Sanofi-Aventis U.S	Packaging Defects	NJ
1 Jun 2016Drug	CLASS I	Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg recalled	Sanofi-Aventis U.S	Labeling Errors	Nationwide
1 Jun 2016Drug	CLASS I	Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg recalled	Sanofi-Aventis U.S	Labeling Errors	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.