The Recall Desk

Manufacturer

Sanofi-Aventis U.S. LLC

22 recalls in our database name Sanofi-Aventis U.S. LLC as the manufacturing or recalling firm.

What the numbers show

Total
22
Critical
1
Severe
14
Most recent
2023-05-24

Of the 22 recalls from Sanofi-Aventis U.S. LLC we have scored against our rubric, 1 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (64%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–22 of 22

  • HighFDA (Drugs)·D-0575-2023·2023-05-24

    ADMELOG Insulin Lispro Recalled for Malformed Seal Defect

    Sanofi-Aventis is recalling 51,325 vials of ADMELOG insulin lispro due to defective seals that may compromise sterility. Affected lot: 3F497B, expires 12-31-2025. Contact your pharmacist if you are using this product.

    Product
    ADMELOG — ADMELOG (INSULIN LISPRO)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0544-2020·2019-12-11

    Sanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Zantac 150 mg tablets nationwide because an NDMA impurity was detected in the product.

    Product
    Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0542-2020·2019-12-11

    Sanofi Recalls Regular Strength Zantac 75 mg Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 75 mg tablets because the FDA detected the NDMA impurity in the product.

    Product
    Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0538-2020·2019-12-11

    Sanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Cool Mint Maximum Strength Zantac 150 mg tablets nationwide because an NDMA impurity was detected.

    Product
    Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-4 41167-0320-5 41167-0320-6 41167-0320-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0543-2020·2019-12-11

    Sanofi Recalls Zantac 75 mg Due to NDMA Impurity

    Sanofi is recalling Regular Strength Zantac 75 mg tablets nationwide because an NDMA impurity was detected in the product.

    Product
    Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0539-2020·2019-12-11

    Sanofi Recalls Maximum Strength Zantac 150 mg Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Maximum Strength Zantac 150 mg tablets nationwide because the FDA detected the NDMA impurity in the product.

    Product
    Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0121-01, 0597-0121-06, 0597-0121-08, 0597-0121-09, 0597-0121-11, 0597-0121-24, 0597-0121-38, 0597-0121-50, 0597-0121-64, 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0545-2020·2019-12-11

    Sanofi Recalls Zantac 75 mg Tablets Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Zantac 75 mg tablets nationwide because NDMA impurity was detected. The recall covers all lots of the product.

    Product
    Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-54 0597-0122-61 0597-0122-81 0597-0122-96
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0540-2020·2019-12-11

    Sanofi Recalls Zantac 75 mg Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 75 mg tablets nationwide because NDMA impurity was detected in the product.

    Product
    Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0534-2020·2019-12-11

    Sanofi Recalls Zantac Tablets Due to NDMA Impurity

    Sanofi is recalling Cool Mint Tablets Maximum Strength Zantac 150 mg nationwide because NDMA impurity was detected in the product.

    Product
    Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0536-2020·2019-12-11

    Sanofi Recalls Maximum Strength Zantac 150 mg Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Maximum Strength Zantac 150 mg tablets nationwide because an NDMA impurity was detected in the product.

    Product
    Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0310-6 41167-0310-7 41167-0310-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0535-2020·2019-12-11

    Sanofi Recalls Zantac 75 mg Tablets Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 75 mg tablets nationwide because NDMA impurity was detected. This action addresses CGMP deviations.

    Product
    Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0541-2020·2019-12-11

    Sanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 150 mg tablets nationwide because an NDMA impurity was detected. This action addresses current good manufacturing practice (CGMP) deviations.

    Product
    Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0537-2020·2019-12-11

    Sanofi Recalls Regular Strength Zantac 150 mg Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 150 mg because the FDA detected the NDMA impurity in the product.

    Product
    Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0925-2018·2018-07-18

    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.

    Product
    ADMELOG — ADMELOG (INSULIN LISPRO)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0804-2018·2018-05-09

    Sanofi Recalls Over-Concentrated Docetaxel Injection Vials Nationwide

    Sanofi-Aventis is recalling 19,580 vials of Docetaxel injection concentrate due to potential over-concentration. The affected lots were distributed nationwide.

    Product
    DOCETAXEL — DOCETAXEL (DOCETAXEL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0153-2018·2018-01-17

    Enoxaparin Sodium Injection Recalled for Labeling Error on Declared Strength

    Sanofi-Aventis is recalling Enoxaparin Sodium injections because a single syringe with a different strength was found in a carton labeled 120 mg/0.8 mL.

    Product
    ENOXAPARIN SODIUM — ENOXAPARIN SODIUM (ENOXAPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0056-2018·2017-11-08

    Sanofi Recalls Clofarabine Injection Vials Due to Incorrect Package Insert

    Sanofi-Aventis is recalling 422 vials of Clofarabine injection because the authorized generic product was packaged with the incorrect package insert for the brand name product.

    Product
    Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0926-2017·2017-07-05

    Gaviscon Chewable Tablets Recalled for High Magnesium Levels

    Sanofi-Aventis is recalling Gaviscon chewable tablets due to high out-of-specification magnesium levels. The recall covers 2,980 bottles distributed in the US, Puerto Rico, and the UK.

    Product
    Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0873-2016·2016-06-01

    Sanofi Recalls Auvi-Q Epinephrine Auto-Injectors Due to Defective Delivery System

    Sanofi-Aventis is recalling 159,000 Auvi-Q epinephrine auto-injectors nationwide because a defective delivery system may result in inaccurate dosage delivery.

    Product
    Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0872-2016·2016-06-01

    Sanofi Recalls Auvi-Q Epinephrine Auto-Injectors Due to Defective Delivery System

    Sanofi-Aventis is recalling Auvi-Q epinephrine auto-injectors because a defective delivery system may result in inaccurate dosage delivery.

    Product
    Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
    Category
    Drug
    Distribution
    Distributed nationwide