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.

9901–9925 of 29157

  • SevereFDA (Devices)·Z-1437-2020·2020-03-11

    FDA Recalls LKT200 Perfusion Circuits Due to Leakage Risk

    Organ Recovery Systems is recalling 2,274 LKT200 Perfusion Circuits because leakage at the sample port could cause loss of perfusion solution needed for kidney preservation.

    Product
    LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic mach
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0966-2020·2020-03-11

    Axia Pharmaceutical Recalls Methylcobalamin Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Methylcobalamin Injection 10mg/100mg/mL 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
    Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0338-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0960-2020·2020-03-11

    Axia Pharmaceutical Recalls Polidocanol Injection Due to Sterility Concerns

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

    Product
    Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-060-3
    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-0955-2020·2020-03-11

    Axia Pharmaceutical Recalls Glycine Injection Due to Sterility Concerns

    Fusion IV Pharmaceuticals is recalling specific lots of Glycine Injection because the company cannot guarantee the product's sterility.

    Product
    Glycine Injection,GLYCINE USP 50MG/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 71283-0344-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0974-2020·2020-03-11

    Axia Pharmaceutical Recalls MIC-PLEX Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling MIC-PLEX Injection in the U.S., Puerto Rico, Barbados, and the Dominican Republic due to a lack of assurance of sterility.

    Product
    MIC-PLEX Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0233-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0962-2020·2020-03-11

    Axia Pharmaceutical Recalls Lidocaine HCL Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Lidocaine HCL 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
    Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For ocular injection, Preservative free, discard unused portion, protect from light, 5 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1011-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0794-2020·2020-03-11

    Grain Processing Recalls Corn Starch Due to Metal Slivers

    Grain Processing Corporation is recalling 3,790 bags of Pure Dent B700 Food Corn Starch because a customer reported the presence of metal slivers.

    Product
    Pure Dent¿ B700 Food Corn Starch packaged in 50 lb bags
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1430-2020·2020-03-11

    Remisol Advance software recalled for remote code execution vulnerability

    Normand-Info S.A.S.U. is recalling Remisol Advance software running on unsupported Windows operating systems due to a critical remote code execution vulnerability.

    Product
    Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Drugs)·D-0933-2020·2020-03-11

    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.

    Product
    Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40 mcg/25 mg/0.5mg/0.01mg/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 71283-0549-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0953-2020·2020-03-11

    Axia Pharmaceutical Recalls Glutathione Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Glutathione Injection because the product lacks assurance of sterility. The recall covers distribution in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1231-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0982-2020·2020-03-11

    Axia Pharmaceutical Recalls Super MIC Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Super MIC Injection, a vitamin complex, due to a lack of assurance of sterility.

    Product
    Super MIC Injection, SUPER MIC* INJECTABLE, Vitamin Complex, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0234-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0973-2020·2020-03-11

    Axia Pharmaceutical Recalls MIC-B12 Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling MIC-B12 Injection because the product lacks assurance of sterility. The recall covers multiple lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML INJECTABLE, For IM Use, Refrigerate. Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0230-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0972-2020·2020-03-11

    Axia Pharmaceutical Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Methylprednisolone Acetate Injectable Suspension because the company cannot guarantee the product is sterile.

    Product
    Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 50 MG/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 71283-0636-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0932-2020·2020-03-11

    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 was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/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 71283-0547-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0941-2020·2020-03-11

    Axia Pharmaceutical Recalls B-Complex 110 Injectable Due to Sterility Concerns

    Axia Pharmaceutical is recalling B-Complex 110 Injectable vials due to a lack of assurance of sterility. The affected lots were distributed nationwide and in several international locations.

    Product
    B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0212-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0965-2020·2020-03-11

    Axia Pharmaceutical Recalls Methionine Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Methionine/Inositol/Choline Injection 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
    Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50MG/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0215-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0939-2020·2020-03-11

    Axia Pharmaceutical Recalls AscorbiX Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling AscorbiX (Buffered C) Injection because the product lacks assurance of sterility. The recall covers specific lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    AscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0977-2020·2020-03-11

    Axia Pharmaceutical Recalls Nicotinamide Adenine Dinucleotide Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Nicotinamide Adenine Dinucleotide (PF) Injection because the FDA determined there is a lack of assurance of sterility.

    Product
    Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 50 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0306-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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 (Drugs)·D-0949-2020·2020-03-11

    Axia Pharmaceutical Recalls Cyanocobalamin/Folinic Acid Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Cyanocobalamin/Folinic Acid Injection because the product lacks assurance of sterility.

    Product
    Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML: 500MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0333-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0978-2020·2020-03-11

    Axia Pharmaceutical Recalls Nicotinamide Adenine Dinucleotide Injection Due to Sterility Concerns

    Fusion IV Pharmaceuticals is recalling specific lots of Nicotinamide Adenine Dinucleotide Injection due to a lack of assurance of sterility.

    Product
    Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 20 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0336-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0994-2020·2020-03-11

    Axia Pharmaceutical Recalls Zinc Chloride Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Zinc Chloride Injection because the product lacks assurance of sterility.

    Product
    Zinc Chloride Injection, ZINC CHLORIDE 10MG/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 71283-0224-3
    Category
    Drug
    Distribution
    Distributed nationwide