The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

10751–10775 of 29158

  • SevereFDA (Drugs)·D-0348-2020·2019-11-20

    Viatrexx-ANS/CNS Recalled for Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling Viatrexx-ANS/CNS vials because they were manufactured in a manner that cannot guarantee sterility.

    Product
    Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0025, NDC 73069-039-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0342-2020·2019-11-20

    Viatrexx-Relief + Sterile Vials Recalled Due to Sterility Assurance Concerns

    Viatrexx Bio Incorporated is recalling Viatrexx-Relief + sterile vials because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Relief +, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0615, NDC 73069-450-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0319-2020·2019-11-20

    Rite Aid Ranitidine Tablets Recalled for Potential NDMA Contamination

    Apotex Inc. is recalling Rite Aid Pharmacy Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA).

    Product
    Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0335-2020·2019-11-20

    Viatrexx-Collagen Recalled for Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling Viatrexx-Collagen vials because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Collagen, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0085, NDC 73069-095-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0228-2020·2019-11-20

    Pacific Coast Fruit Company Recalls Winter Citrus Slaw Kit for Listeria Risk

    Pacific Coast Fruit Company is recalling Winter Citrus Slaw Kits due to potential Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.

    Product
    Winter Citrus Slaw Kit, item #71909, UPC 20728 71909. There are 2/7.2 lbs. bags of multiple ingredients per kit. Each kit contains multiple products and 4/12 oz. bags of Mann Packing Broccoli Cole Slaw: -Mann Packing Broccoli Cole Slaw (4/12 oz bags). -Bacon pieces -Red on
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0344-2020·2019-11-20

    Viatrexx-Facial Vials Recalled Due to Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling 13 vials of Viatrexx-Facial because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Facial, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0184, NDC 73069-164-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0318-2020·2019-11-20

    Apotex Recalls Equate Ranitidine Tablets Due to NDMA Contamination

    Apotex Inc. is recalling Equate Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA). The recall covers 162,344 bottles distributed nationwide.

    Product
    Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0146-2020·2019-11-20

    Country Baking Company Recalls Chocolate Chip Cookie Dough Due to Allergy Complaint

    California New Foods is recalling Country Baking Company chocolate chip cookie dough after a consumer reported an allergic reaction.

    Product
    Country Baking Company; Pre-scooped & Ready to Bake: Chocolate Chip Cookie Dough All Natural, No Preservatives NET Wt. 24 ox. (1 lb. 8 oz.) Bakes 12 Jumbo cookies UPC Code 736211713483
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0346-2020·2019-11-20

    Viatrexx-Neuro Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Neuro vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide.

    Product
    Viatrexx-Neuro, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0460, NDC 73069-375-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0370-2020·2019-11-20

    Avanos Medical Recalls CORFLO PEG Kits Due to Connector Defect

    Avanos Medical is recalling CORFLO PEG Kits because the connector piece does not pass over the guidewire. The recall affects 104 cases distributed to six US states and Great Britain.

    Product
    CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0327-2020·2019-11-20

    Viatrexx-MuSkel-Neural Recalled Due to Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling Viatrexx-MuSkel-Neural vials because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC4020, NDC 73069-347-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0313-2020·2019-11-20

    Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Novitium Pharma LLC is recalling Ranitidine Capsules 300 mg because of the presence of the NDMA impurity. The recall covers 6,660 bottles distributed nationwide.

    Product
    Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0345-2020·2019-11-20

    Viatrexx-Hair Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Hair sterile multi-dose vials because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0251, NDC 73069-206-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0334-2020·2019-11-20

    Viatrexx-Infla Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Infla vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide and in Puerto Rico.

    Product
    Viatrexx-Infla, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0279, NDC 73069-249-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0331-2020·2019-11-20

    Viatrexx-Systemic Detox Recalled Due to Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling Viatrexx-Systemic Detox vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide.

    Product
    Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0665, NDC 73069-500-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0332-2020·2019-11-20

    Viatrexx-Articula Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Articula vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide and in Puerto Rico.

    Product
    Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0031, NDC 73069-037-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0308-2020·2019-11-20

    GSMS Recalls Ranitidine Capsules Due to NDMA Impurity Detection

    Golden State Medical Supply Inc. is recalling specific lots of Ranitidine Capsules 300 mg because the FDA detected the NDMA impurity in the product.

    Product
    GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
    Category
    Drug
    Distribution
    4 states
  • SevereNHTSA·19V835000·2019-11-20

    Isuzu and Chevrolet Trucks Recalled for Rear Wheel Lug Nut Defect

    Isuzu is recalling certain 2017-2020 Isuzu and Chevrolet trucks because rear outer wheel lug nuts may not have been properly tightened, increasing crash risk.

    Product
    ISUZU — ISUZU, CHEVROLET NPR HD, NPR XD, NQR, NRR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0142-2020·2019-11-20

    Frozen Cookie Doughballs Recalled Due to Allergic Reaction Complaint

    California New Foods is recalling 8,923 cases of Carolyn's Cookie Company Frozen Cookie Doughballs after a consumer reported an allergic reaction.

    Product
    Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at Home. Double Chocolate with Sea Salt Net Wt. 22 oz. (623.7g) UPC Code 680569160263
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0343-2020·2019-11-20

    Viatrexx-Intra-Cell Recalled Due to Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling Viatrexx-Intra-Cell vials because they were manufactured in a manner that cannot guarantee sterility.

    Product
    Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0280, NDC 73069-250-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0141-2020·2019-11-20

    Carolyn's Cookie Company Recalls Frozen Cookie Doughballs Due to Allergy Complaint

    California New Foods is recalling Carolyn's Cookie Company frozen cookie doughballs after a consumer reported an allergic reaction.

    Product
    Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at Home. Chocolate Chip Tasted Walnut Net Wt. 22 oz. (623.7g) UPC Code 680569160249
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0307-2020·2019-11-20

    GSMS Recalls Ranitidine Capsules Due to NDMA Impurity Detection

    Golden State Medical Supply Inc. is recalling specific lots of Ranitidine Capsules 150 mg because the FDA detected the NDMA impurity in the product.

    Product
    GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0314-2020·2019-11-20

    Apotex Recalls Walgreens Wal-Zan 150 Tablets Due to NDMA Contamination Risk

    Apotex Inc. is recalling Walgreens Maximum Strength Wal-Zan 150 tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA).

    Product
    Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0360-2020·2019-11-20

    Canon Medical Recalls Infinix DP-i Catheterization Tables Due to Unintended Tilting

    Canon Medical System, USA, INC. is recalling nine Infinix DP-i catheterization tables because liquid spills can trigger a short circuit, causing the table to tilt without operator control.

    Product
    Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0338-2020·2019-11-20

    Viatrexx-Mesenchyme Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Mesenchyme vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide.

    Product
    Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0092, NDC 73069-102-41.
    Category
    Medical Device
    Distribution
    Distributed nationwide