The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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4051–4075 of 11852

  • SevereFDA (Drugs)·D-0570-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl PCA Vials Due to Glass Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl PCA vials due to the potential presence of glass particulate matter.

    Product
    fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1180-79
    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-0567-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Injection Bags Due to Glass Particulates

    QuVa Pharma is recalling fentanyl injection bags due to the potential presence of glass particulates.

    Product
    fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1444-05
    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-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-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-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-0547-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Bupivacaine Bags Due to Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl and bupivacaine injection bags due to the presence of particulate matter, including potential glass particles.

    Product
    fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0569-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Bags Due to Glass Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl 2500 mcg/50 mL bags nationwide due to the presence of glass particulate matter.

    Product
    fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0551-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter

    QuVa Pharma is recalling fentanyl syringes due to the potential presence of glass particulate matter. The recall is classified as FDA Class II.

    Product
    fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1099-49
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0565-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Bupivacaine Injection Due to Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl and bupivacaine injection due to the presence of particulate matter, including potential glass particles.

    Product
    fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Free 100 mL in 150 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1103-36
    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
  • HighFDA (Drugs)·D-0550-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Bupivacaine Injection Due to Particulate Matter

    QuVa Pharma is recalling fentanyl and bupivacaine injection bags due to the presence of particulate matter, specifically potential glass particles.

    Product
    fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free, 100 mL in 150 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1104-36
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0560-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter

    QuVa Pharma is recalling fentanyl 250 mcg/5 mL syringes due to the presence of glass particulate matter. The recall is nationwide.

    Product
    fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1098-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0566-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl syringes because they may contain glass particulate matter.

    Product
    fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1415-47
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0555-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Infusions Due to Glass Particulate Matter

    QuVa Pharma is recalling fentanyl 10 mcg/mL infusion bags nationwide due to the potential presence of glass particulate matter.

    Product
    fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1092-36
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0533-2020·2019-12-11

    Fagron Recalls LETS GEL Kits Due to Microbial Contamination

    Fagron, Inc. is recalling 11,912 kits of LETS GEL Convenience Packs due to microbial contamination of the non-sterile product.

    Product
    LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0548-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Ropivacaine Infusions Due to Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl and ropivacaine infusions due to the presence of particulate matter, including potential glass particles.

    Product
    fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0553-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Infusion Bags Due to Glass Particulates

    QuVa Pharma is recalling fentanyl infusion bags because they may contain glass particulates. The affected product is distributed nationwide.

    Product
    fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0557-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Bupivacaine Injection Due to Particulate Matter

    QuVa Pharma is recalling fentanyl and bupivacaine injection products due to the presence of particulate matter, specifically potential glass particles.

    Product
    fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1202-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0526-2020·2019-12-04

    AuroMedics Recalls Ranitidine Tablets Due to NDMA Detection

    AuroMedics Pharma LLC is recalling DG Health Acid Reducer Ranitidine Tablets 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.

    Product
    DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0524-2020·2019-12-04

    AVKARE Recalls Ranitidine Tablets Due to NDMA Impurity

    AVKARE Inc. is recalling specific lots of Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0573-2020·2019-12-04

    AuroMedics Recalls MARLIDO KIT Vials Due to Foreign Material Presence

    AuroMedics Pharma LLC is recalling MARLIDO KIT vials because foreign material was found inside the vials. The affected product is Lidocaine HCl Injection, USP, 2%.

    Product
    MARLIDO KIT — MARLIDO KIT (MARCAINE, LIDOCAINE, POVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0531-2020·2019-12-04

    Ibuprofen Oral Suspension Recalled for Inert Plastic Particles

    Preferred Pharmaceuticals is recalling specific lots of Ibuprofen Oral Suspension USP due to the presence of small particles of inert plastic material.

    Product
    Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0525-2020·2019-12-04

    AVKARE Recalls Ranitidine Tablets Due to NDMA Impurity

    AVKARE Inc. is recalling specific lots of Ranitidine Tablets 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
    Category
    Drug
    Distribution
    Distributed nationwide