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.

12201–12225 of 29164

  • SevereFDA (Drugs)·D-1192-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Gentamicin Sterile Water for Irrigation

    Anderson Compounding Pharmacy is recalling Gentamicin 160 mg/1000 mL Sterile Water for Irrigation due to a lack of sterility assurance.

    Product
    Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1127-2019·2019-04-24

    MSM Nutraceuticals Recalls Dry Eye Eye Drops for Sterility Concerns

    MSM Nutraceuticals is recalling Dry Eye Eye Drops because the product was not terminally sterilized and was not tested per USP 71.

    Product
    Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, Net Wt. 15ml, 0.51 fl oz., Manufactured by: MSM Nutraceuticals, LLC, UPC 8 54582 00119 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1147-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling HCG 11,000 Units vials nationwide because the product lacks sterility assurance.

    Product
    HCG 11,000 Units, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1150-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling 57 vials of HCG 30 Day due to a lack of sterility assurance. The products were distributed nationwide.

    Product
    HCG 30 Day, 3750 Units/6 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN 1-800-263-8890
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1170-2019·2019-04-24

    Prostaglandin Vials Recalled Due to Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Prostaglandin 60 mcg/mL vials nationwide due to a lack of sterility assurance.

    Product
    Prostaglandin 60 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V321000·2019-04-24

    LDJ Recalls 2017-2018 R250 Trailers Due to Axle Installation Defects

    LDJ is recalling 2017-2018 R250 Container trailers because axles may be installed backwards or unwelded, potentially causing brake failure and increasing crash risk.

    Product
    LDJ — LDJ R250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1139-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Amphotericin B Eye Drops for Sterility Concerns

    Anderson Compounding Pharmacy is recalling Amphotericin B 0.15% Eye Drops due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Amphotericin B 0.15% Eye Drops, 2 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1191-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Heparin and Marcaine Syringes for Sterility Concerns

    Anderson Compounding Pharmacy is recalling Heparin and Marcaine syringes due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1153-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG 23 Day Injection Vials

    Anderson Compounding Pharmacy is recalling HCG 23 Day Injection Extra Strength vials nationwide due to a lack of sterility assurance.

    Product
    HCG 23 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN 1-800-263-8890
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1167-2019·2019-04-24

    Polyhexamethylene Biguanide Ophthalmic Drops Recalled for Sterility Assurance Issues

    Anderson Compounding Pharmacy is recalling Polyhexamethylene Biguanide 0.02% Ophthalmic Drops due to a lack of sterility assurance.

    Product
    Polyhexamethylene Biguanide 0.02% Ophthalmic Drops, 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1179-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Streptomycin and Dexamethasone Otic Injection

    Anderson Compounding Pharmacy is recalling Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection due to a lack of sterility assurance.

    Product
    Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection, 1 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1179-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Energy Risk

    Gyrus ACMI, Inc. is recalling Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with Olympus consoles.

    Product
    Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1164-2019·2019-04-24

    Morphine Sulfate Inhalation Vials Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Morphine Sulfate 5 mg/3mL inhalation vials due to a lack of sterility assurance. The recall covers 60 vials distributed nationwide.

    Product
    Morphine Sulfate 5 mg/3mL Inhalation, 3 mL Vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1142-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls DMSO and Heparin Syringes for Sterility Concerns

    Anderson Compounding Pharmacy is recalling DMSO 50% and Heparin syringes due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 mL syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1147-2019·2019-04-24

    Roche Tina-quant IgM Gen.2 Recalled for Endogenous Interference

    Roche Diagnostics is recalling Tina-quant IgM Gen.2 assays due to new endogenous interference claims that may pose a medical risk on specific analyzers.

    Product
    Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1160-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Heparin and Lidocaine Syringes for Sterility Concerns

    Anderson Compounding Pharmacy is recalling Heparin and Lidocaine syringes due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1186-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Blades Due to RF Energy Activation Risk

    Gyrus ACMI, Inc. is recalling Diego Elite Blades Monopolar because they may allow unintended RF energy activation when used with Olympus consoles.

    Product
    Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1195-2019·2019-04-24

    Estrone Oil Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Estrone 5mg/mL Oil Injection nationwide due to a lack of sterility assurance.

    Product
    Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1137-2019·2019-04-24

    Acetylcysteine Eye Drops Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Acetylcysteine 10% Ophthalmic Eye Drops due to a lack of sterility assurance.

    Product
    Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1201-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Prostaglandin Tri-Mix Injection Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling Prostaglandin Tri-Mix Injection vials because they lack sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1176-2019·2019-04-24

    Sermorelin Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Sermorelin 0.4 mg/0.5 mL vials nationwide due to a lack of sterility assurance.

    Product
    Sermorelin 0.4 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1146-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG Injection Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling HCG 1,000 U/mL Injection vials nationwide due to a lack of sterility assurance.

    Product
    HCG 1,000 U/mL Injection, 30 mL, Vial Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide