The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

14526–14550 of 29192

  • SevereFDA (Drugs)·D-0644-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling 7 vials of Testosterone Cypionate 200mg/mL in Nevada because the firm used a non-approved method of sterilization.

    Product
    Testosterone Cypionate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1381-2018·2018-04-25

    Nutrizone LLC Recalls Cali Thai Kratom Due to Salmonella Risk

    Nutrizone LLC is recalling all packages of Cali Thai Kratom because dietary supplements may be contaminated with Salmonella.

    Product
    Cali Thai Kratom all packages, all quantities
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1461-2018·2018-04-25

    Cook Vacuum Pump Recalled for Electrical Shock and Burn Risk

    Cook Inc. is recalling 2,267 Cook Vacuum Pumps (K-MAR-5200-US) worldwide due to defective crimp connectors that may cause device failure, electric shock, or burns.

    Product
    Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1385-2018·2018-04-25

    Nutrizone Recalls Nirvanio Kratom Supplements Due to Salmonella Risk

    Nutrizone LLC is recalling all packages of Nirvanio Special Reserve Kratom because dietary supplements can be contaminated with Salmonella.

    Product
    Nirvanio Special Reserve Kratom all packages, all quantities
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0674-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Estradiol Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Estradiol 12.5 mg pellets in Nevada due to a non-approved sterilization method.

    Product
    Estradiol 12.5 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0634-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Ascorbic Acid Vials Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Ascorbic Acid (Tapioca) 500 mg/mL vials because they were sterilized using a non-approved method.

    Product
    Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·18V261000·2018-04-25

    Lakota Recalls 2018-2019 Trailers Due to Ramp Bolt Failure Risk

    Lakota is recalling 2018-2019 Bighorn, Charger, and Colt trailers because ramp-securing bolts may loosen or break, increasing the risk of injury or a crash.

    Product
    LAKOTA — LAKOTA COLT, BIGHORN, CHARGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0637-2018·2018-04-25

    Partell Specialty Pharmacy Recalls CoEnzymeQ10 Vials Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling CoEnzymeQ10 25mg/mL vials because they were sterilized using a non-approved method.

    Product
    CoEnzymeQ10 25mg/mL, 5mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0663-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone 100 mg pellets in Nevada because they were sterilized using a non-approved method.

    Product
    Testosterone 100 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1112-2018·2018-04-25

    Aspire Food Group Recalls EXO Cricket Protein Bars for Undeclared Sulfites

    Aspire Food Group is recalling EXO Cricket Protein Bars in Peanut Butter and Jelly flavor because they contain undeclared sulfites. The affected units were distributed in the United States and Germany.

    Product
    EXO Cricket Protein Bar Peanut Butter and Jelly; Net Wt 2.1 Oz. packaged in a film wrapper, 12 units per case; UPC: 861703000014
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1020-2018·2018-04-25

    Divinity Kratom Capsules Recalled Due to Unapproved New Dietary Ingredient

    Divinity Product Distribution LLC is recalling kratom capsules because the ingredient lacks adequate safety information to ensure it does not present a significant risk of illness or injury.

    Product
    Kratom capsules labeled in the following ways: 1) Divinity Kratom 10 Capsule Dietary Supplement, Divinity Product LLC, Blue Springs, MO 64015; 2) Divinity Bali Kratom, 10PK Capsules; 3) Divinity Bali Kratom, 20PK Capsules; 4) Divinity Bali Kratom, 40PK Capsules;
    Category
    Food
    Distribution
    44 states
  • SevereFDA (Drugs)·D-0658-2018·2018-04-25

    Partell Specialty Pharmacy Recalls TM #4 Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling TM #4 drug products because a non-approved method of sterilization was used.

    Product
    TM #4 (ALP 20/PAPAV/PHENT 2), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0643-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Nandrolone Decanoate Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Nandrolone decanoate 200mg/mL vials because they were sterilized using a non-approved method.

    Product
    Nandrolone decanoate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0650-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Progesterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling specific lots of Progesterone 50 mg pellets in Nevada because the products were sterilized using a non-approved method.

    Product
    Progesterone 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 twist top surrounded by a wrapper,
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0651-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone/Anastrozole Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone/Anastrozole pellets because they were sterilized using a non-approved method.

    Product
    Testosterone/Anastrozole 120 mg/8 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0655-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Methylcobalamin Injectable Liquid Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Methylcobalamin 12.5 mg/mL Injectable Liquid in Nevada due to a non-approved method of sterilization.

    Product
    Methylcobalamin 12.5 mg/mL, Injectable Liquid, packaged in a) 5 mL amber vial, and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0639-2018·2018-04-25

    Partell Specialty Pharmacy Recalls HCG Vials Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling HCG 1000 units/mL vials in Nevada because a non-approved sterilization method was used.

    Product
    HCG 1000 units/mL, packaged in a) 2 mL and b) 6 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0654-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone/Finasteride/Anastrozole pellets because they were sterilized using a non-approved method.

    Product
    Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1021-2018·2018-04-25

    Kratom Powder Recalled Due to Inadequate Safety Information for New Ingredient

    Divinity Product Distribution LLC is recalling kratom powder products because the ingredient lacks sufficient safety data to ensure it does not pose a risk of illness or injury.

    Product
    Kratom powder labeled in the following ways 1) Enhance Your Life, Kratom Essence Maeng Da Mitragyna speciosa, 150 gras; 2) Bali Kratom, 15 g Powdered; 3) Bali Kratom, 30 g Powdered; 4) Bali Kratom, 60 g Powdered; 5) Bali Kratom, 120 g Powdered; 6) Botany Bay, 1 oz
    Category
    Food
    Distribution
    44 states
  • SevereFDA (Drugs)·D-0662-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone 200 mg pellets in Nevada because they were sterilized using a non-approved method.

    Product
    Testosterone 200 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·18V265000·2018-04-25

    Lakota Recalls 2018-2019 Trailers Due to Ramp Detachment Risk

    Lakota is recalling 2018-2019 Bighorn, Charger, and Colt trailers because missing hardware may allow the rear ramp to detach while moving, increasing crash risk.

    Product
    LAKOTA — LAKOTA BIGHORN, CHARGER, COLT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0671-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone/Anastrozole pellets because a non-approved sterilization method was used, raising concerns about sterility assurance.

    Product
    Testosterone/Anastrozole 60 mg/1 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0669-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone 80 mg pellets in Nevada because they were sterilized using a non-approved method.

    Product
    Testosterone 80 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0642-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Methionine Injection Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Methionine 25mg/Inositol 50mg/Choline 50mg/B12 1mg injections because they were sterilized using a non-approved method.

    Product
    Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL amber vial and b) 50mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state