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.

12226–12250 of 29164

  • SevereFDA (Devices)·Z-1185-2019·2019-04-24

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

    Gyrus ACMI is recalling 21 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with specific consoles.

    Product
    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1126-2019·2019-04-24

    MSM Eye Drops Recalled for Lack of Sterility Assurance

    MSM Nutraceuticals is recalling 15% MSM Eye Drops because the product is not terminally sterilized and was not tested per USP 71.

    Product
    15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC 2103 West Parkside Lane, Ste.107, Phoenix, AZ 85027, UPC 8 54582 00120 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1180-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Bacitracin Irrigation Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling Bacitracin 3000U/30 mL Irrigation syringes nationwide due to a lack of sterility assurance.

    Product
    Bacitracin 3000U/30 mL Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1189-2019·2019-04-24

    FDA Recalls EDTA 1% Sterile Injection Due to Sterility Assurance Issues

    Anderson Compounding Pharmacy is recalling EDTA 1% Sterile Injection (Preservative Free) nationwide due to a lack of sterility assurance.

    Product
    EDTA 1% Sterile Injection (Preservative Free), Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1185-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Interferon Eye Drops for Sterility Concerns

    Anderson Compounding Pharmacy is recalling Interferon 1 Million IU/mL Eye Drops due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Interferon 1 Million IU/mL Eye Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1178-2019·2019-04-24

    Serum Tears 30% Drops Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Serum Tears 30% Drops due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Serum Tears 30% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1172-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Prostaglandin Quad Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling Prostaglandin Quad with Atropine vials because the product lacks sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Prostaglandin Quad with Atropine 10:30:1:0.15, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1129-2019·2019-04-24

    MSM Nutraceuticals Recalls Dr. Berne's MSM Drops Due to Sterility Concerns

    MSM Nutraceuticals is recalling 500 bottles of Dr. Berne's MSM Drops because the product lacks assurance of sterility and was not tested per USP 71.

    Product
    Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hillsboro Technology Drive, Deerfield BEach, FL 33441 SKU#182 UPC 00854582001036
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1197-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Papaverine and Phentolamine Vials

    Anderson Compounding Pharmacy is recalling Papaverine 30 mg/Phentolamine 0.5 mg/mL vials due to a lack of sterility assurance.

    Product
    Papaverine 30 mg/Phentolamine 0.5 mg/mL, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1154-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG Injection Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling HCG 4,100 Units/vial Injection nationwide due to a lack of sterility assurance.

    Product
    HCG 4,100 Units/vial Injection, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1182-2019·2019-04-24

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

    Gyrus ACMI is recalling 247 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with Olympus consoles.

    Product
    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1173-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Prostaglandin Tri-Mix Vials for Sterility Concerns

    Anderson Compounding Pharmacy is recalling 58 vials of Prostaglandin Tri-Mix 20:30:1 due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Prostaglandin Tri-Mix 20:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1196-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG Injection Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling HCG 11,000 mcg Injection vials nationwide due to a lack of sterility assurance.

    Product
    HCG 11,00Units/B 12 11,000 mcg Injection, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1128-2019·2019-04-24

    MSM Red Eye Eye Drops Recalled for Sterility Assurance Issues

    MSM Nutraceuticals is recalling Red Eye Eye Drops because the product lacks assurance of sterility and was not tested per USP 71.

    Product
    Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15 fl oz., Manufactured by: MSM Nutraceuticals, LLC , UPC 8 54582 00118 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1188-2019·2019-04-24

    Lidocaine Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Lidocaine 1%/Dextrose 12.5% Injection vials due to a lack of sterility assurance.

    Product
    Lidocaine 1%/Dextrose 12.5% (PF) Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1144-2019·2019-04-24

    Gentamicin Irrigation Syringes Recalled for Lack of Sterility Assurance

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

    Product
    Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1166-2019·2019-04-24

    Phenylephrine Injection Recalled Due to Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Phenylephrine 1 mg/mL Injection vials nationwide because the product lacks sterility assurance.

    Product
    Phenylephrine 1 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1175-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Sermorelin Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling 22 vials of Sermorelin 0.3 mg/0.5 mL nationwide due to a lack of sterility assurance.

    Product
    Sermorelin 0.3 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1200-2019·2019-04-24

    Prostaglandin Tri-Mix Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Prostaglandin Tri-Mix Injection due to lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Prostaglandin Tri-Mix 5:15:0.5 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1094-2019·2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate

    ICU Medical is recalling specific lots of ChemoClave Vial Spikes because they may contain plastic burr particulate from the protective cap used during assembly.

    Product
    icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1156-2019·2019-04-24

    Heparin and Lidocaine Syringes Recalled for Lack of Sterility Assurance

    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 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Water 5 mL, 27 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1186-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Prostaglandin Tri-Mix Injection for Sterility Concerns

    Anderson Compounding Pharmacy is recalling Prostaglandin Tri-Mix 60:30:1 Injection due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Prostaglandin Tri-Mix 60:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1151-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling 99 vials of HCG 20 Day Extra Strength nationwide due to a lack of sterility assurance.

    Product
    HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1162-2019·2019-04-24

    Methylcobalamin Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Methylcobalamin 1 mg/mL Injection vials due to a lack of sterility assurance.

    Product
    Methylcobalamin 1 mg/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1182-2019·2019-04-24

    FDA Recalls Vitamin D3 Injection Due to Sterility Assurance Concerns

    Anderson Compounding Pharmacy is recalling Vitamin D3 200,000 IU/mL Injection vials nationwide due to a lack of sterility assurance.

    Product
    Vitamin D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide