Sanofi-Aventis U.S. LLC
Complete recall history across all FDA and CPSC categories — 22 total recalls
Sanofi-Aventis U.S. LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (22)
FDA drug safety enforcement actions by Sanofi-Aventis U.S. LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 11, 2023 | Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial,... | Lack of Assurance of Sterility: Malformed crimped collar seal | Class II |
| Aug 10, 2020 | Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Ave... | Failed Stability Specifications: Out of Specification result for enzyme activ... | Class II |
| Oct 22, 2019 | Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Compan... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II |
| Oct 22, 2019 | Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, ... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II |
| Oct 22, 2019 | Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Compa... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II |
| Oct 22, 2019 | Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II |
| Oct 22, 2019 | Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sa... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II |
| Oct 22, 2019 | Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Compa... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II |
| Oct 22, 2019 | Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Compan... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II |
| Oct 22, 2019 | Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II |
| Oct 22, 2019 | Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219,... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II |
| Oct 22, 2019 | Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II |
| Oct 22, 2019 | Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II |
| Oct 22, 2019 | Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chatt... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II |
| Jul 5, 2018 | Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection,... | Temperature Abuse: Product samples of Admelog may not have been shipped at pr... | Class II |
| Apr 27, 2018 | Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. ... | Superpotent drug: over-concentrated vials of Docetaxel injection concentrate ... | Class II |
| Dec 5, 2017 | Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count ... | Labeling: Label Error on Declared Strength. A single syringe labeled as 150 m... | Class III |
| Oct 13, 2017 | Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: T... | Labeling: Incorrect or Missing Package Insert: authorized generic product was... | Class III |
| Jun 12, 2017 | Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor C... | Superpotent Drug: high out-of-specification result for magnesium. | Class III |
| Sep 1, 2016 | Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx ... | Labeling: Incorrect or Missing Package Insert | Class III |
| Oct 28, 2015 | Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled au... | Defective Delivery System; potential to have inaccurate dosage delivery | Class I |
| Oct 28, 2015 | Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled aut... | Defective Delivery System; potential to have inaccurate dosage delivery | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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