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

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 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, 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, 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

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.