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.

9951–9975 of 29157

  • SevereFDA (Drugs)·D-0934-2020·2020-03-11

    Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine/Atropine Injection due to a lack of assurance of sterility. The product is distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 60 mcg/30 mg/2 mg/0.15mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0550-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0952-2020·2020-03-11

    Axia Pharmaceutical Recalls Dexpanthenol Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Dexpanthenol Injection due to a lack of assurance of sterility. The affected lots were distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0214-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0980-2020·2020-03-11

    Axia Pharmaceutical Recalls Pyridoxine Hydrochloride Injection Due to Sterility Concerns

    Fusion IV Pharmaceuticals is recalling specific lots of Pyridoxine Hydrochloride Injection due to a lack of assurance of sterility. The product was distributed nationwide and in several Caribbean territories.

    Product
    Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0216-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0991-2020·2020-03-11

    Axia Pharmaceutical Recalls Triamcinolone Diacetate Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate Injectable Suspension because the product lacks assurance of sterility.

    Product
    Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0945-2020·2020-03-11

    Axia Pharmaceutical Recalls Biotin Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling Biotin Injectable Suspension due to a lack of assurance of sterility. The product was distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0220-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0935-2020·2020-03-11

    Axia Pharmaceutical Recalls Alprostadil Injectable Due to Sterility Concerns

    Axia Pharmaceutical is recalling Alprostadil injectable vials due to a lack of assurance of sterility. The affected product is distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0538-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0942-2020·2020-03-11

    Axia Pharmaceutical Recalls Betamethasone Injectable Suspension Due to Sterility Concerns

    Fusion IV Pharmaceuticals is recalling specific lots of Betamethasone Injectable Suspension because the company cannot guarantee the product is sterile.

    Product
    BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [2ML] 6MG/ML INJ SUSP, For IM, IA, IT Use, Shake Well. Preservative Free. Discard Unused Portion, 2 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. St
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0983-2020·2020-03-11

    Axia Pharmaceutical Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Testosterone Cypionate Injection because the company cannot guarantee the product is sterile.

    Product
    Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML INJECTABLE, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0956-2020·2020-03-11

    Axia Pharmaceutical Recalls hCG Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Human Chorionic Gonadotropin (hCG) Injection due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0533-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0765-2020·2020-03-11

    Whole Foods Recalls Marble Bundt Cake Slices Due to Undeclared Milk

    Whole Foods Market is recalling 241 slices of Marble Bundt Cake sold in specific states because the product contains undeclared milk.

    Product
    Marble Bundt Cake sold by the slice packaged in Self Serve and Plastic clam shell containers PLU 45162
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0979-2020·2020-03-11

    Axia Pharmaceutical Recalls Iohexol Injection Due to Sterility Concerns

    Fusion IV Pharmaceuticals is recalling Iohexol Injection due to a lack of assurance of sterility. The affected product is distributed nationwide and in specific international locations.

    Product
    Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1413-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0968-2020·2020-03-11

    Axia Pharmaceutical Recalls Methylprednisolone Acetate/Bupivacaine Injectable Suspension

    Axia Pharmaceutical is recalling Methylprednisolone Acetate/Bupivacaine Injectable Suspension due to a lack of assurance of sterility.

    Product
    Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIV [10ML] CMC 40MG/5MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0623
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0767-2020·2020-03-11

    Whole Foods Recalls Chocolate Dipped Coconut Macaroon Cookies for Undeclared Milk

    Whole Foods Market is recalling 109 chocolate dipped coconut macaroon cookies due to undeclared milk. The cookies were sold in seven states and Washington D.C.

    Product
    Chocolate Dipped Coconut Macaroon Cookie sold by the individual cookie packaged in Self Serve and Plastic clam shell containers PLU 48454
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0944-2020·2020-03-11

    Axia Pharmaceutical Recalls Betamethasone Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling Betamethasone Acetate/Betamethasone Injectable Suspension due to a lack of assurance of sterility. The product was distributed nationwide and in several territories.

    Product
    BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [5ML] 7MG/ML INJ SUSP, For IM, IA Use, Shake Well. 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0621-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0990-2020·2020-03-11

    Axia Pharmaceutical Recalls Triamcinolone Diacetate Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate Injectable Suspension because the company cannot assure the sterility of the product.

    Product
    Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0628-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0963-2020·2020-03-11

    Axia Pharmaceutical Recalls Lysine Hydrochloride Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Lysine Hydrochloride Injection because the company cannot ensure the product is sterile.

    Product
    Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0342-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0959-2020·2020-03-11

    Axia Pharmaceutical Recalls Arginine Hydrochloride Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Arginine Hydrochloride Injection because the product lacks assurance of sterility.

    Product
    Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0341-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0961-2020·2020-03-11

    Axia Pharmaceutical Recalls Levocarnitine Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Levocarnitine Injection because the company cannot guarantee the product's sterility.

    Product
    Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-9260-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V137000·2020-03-09

    Ford Recalls 2019 Rangers for HVAC Blower Motor Fire Risk

    Ford is recalling 2019 Rangers previously repaired under recall 19V-726 because the replacement HVAC blower motor may have an electrical short that increases fire risk.

    Product
    FORD — FORD RANGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V133000·2020-03-06

    Micro Bird Recalls School and Transit Buses for Emergency Door Defect

    Micro Bird is recalling 2004-2021 school and transit buses because the emergency door retaining device may fail to keep the door open, increasing injury risk during evacuation.

    Product
    MICRO BIRD — MICRO BIRD T-SERIES SCHOOL BUS, T-SERIES TRANSIT BUS, MB II SCHOOL BUS, MB II TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V135000·2020-03-06

    Volkswagen Recalls 2019 Arteon Vehicles for Brake Booster Defect

    Volkswagen is recalling 2019 Arteon vehicles because an incorrectly installed electronic brake booster rod may increase braking force or disconnect, raising crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN ARTEON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·20720·2020-03-05

    RH Recalls Camino Floor Lamps Due to Fire Hazard

    RH is recalling about 800 Camino floor lamps sold in the U.S. because the foot switch can overheat or catch fire, posing a fire hazard.

    Product
    Camino Floor Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V132000·2020-03-04

    Peterbilt 320 and 520 Trucks Recalled for Brake Signal Hose Defect

    PACCAR is recalling 2016-2020 Peterbilt 320 and 520 trucks because a missing quick release valve may delay brake release, increasing crash risk.

    Product
    PETERBILT — PETERBILT 320, 520
    Category
    Vehicle
    Distribution
    Distributed nationwide