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.

12176–12200 of 29164

  • SevereFDA (Drugs)·D-1168-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Prostaglandin Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling 23 vials of Prostaglandin 20 mcg/mL due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Prostaglandin 20 mcg/mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1148-2019·2019-04-24

    FDA Recalls HCG 20 Day Injection Due to Sterility Concerns

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

    Product
    HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1082-2019·2019-04-24

    Brainlab Spine & Trauma 3D Navigation Software Recall for Display Error

    Brainlab AG is recalling Spine & Trauma 3D Navigation 1.0 software because it may display fixed image planes instead of the desired inline view, potentially preventing surgeons from determining instrument position.

    Product
    Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1157-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Heparin and Marcain Syringes for Sterility Concerns

    Anderson Compounding Pharmacy is recalling specific 60 mL syringes containing Heparin, Marcain, Sodium Bicarbonate, and Normal Saline due to a lack of sterility assurance.

    Product
    Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Saline 5 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1159-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Heparin and Marcain Syringes for Sterility Concerns

    Anderson Compounding Pharmacy is recalling 12 syringes of a Heparin, Marcain, and Sodium Bicarbonate mixture due to a lack of sterility assurance.

    Product
    Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1194-2019·2019-04-24

    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 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1171-2019·2019-04-24

    Prostaglandin Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Prostaglandin Quad-Mix Injection vials due to a lack of sterility assurance.

    Product
    Prostaglandin Quad-Mix 20:30:1:0.15 Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1149-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG 23 Day Vials for Sterility Concerns

    Anderson Compounding Pharmacy is recalling HCG 23 Day vials nationwide due to a lack of sterility assurance. Consumers should stop using the product.

    Product
    HCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1155-2019·2019-04-24

    FDA Recalls HCG 40 Day Injection Vials for Sterility Concerns

    Anderson Compounding Pharmacy is recalling HCG 40 Day Injection Extra Strength vials nationwide due to a lack of sterility assurance.

    Product
    HCG 40 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1138-2019·2019-04-24

    FDA Recalls Atropine Eye Drops Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling Atropine 0.01% Eye Drops because the product lacks sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Atropine 0.01% Eye Drops, 1 mL and 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1193-2019·2019-04-24

    Gentamicin Sterile Water Recall Due to Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Gentamicin 240 mg/500 mL Sterile Water for Irrigation due to a lack of sterility assurance.

    Product
    Gentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1158-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Heparin and Bupivacaine Syringes

    Anderson Compounding Pharmacy is recalling Heparin 10,000 U/Bupivacaine 0.5% syringes due to a lack of sterility assurance.

    Product
    Heparin 10,000 U/Bupivacaine 0.5% 10 mL, Sodium Bicarbonate 8.4% 50 mL, 61 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·048-2019·2019-04-24

    Grant Park Packing Recalls Raw Ground Beef Due to E. coli O103

    Grant Park Packing is recalling approximately 53,200 pounds of raw ground beef that may be contaminated with E. coli O103. The products were shipped to Minnesota and Kentucky.

    Product
    Grant Park Packing — Grant Park Packing Recalls Raw Ground Beef Products Due to Possible E. coli O103 Contamination
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1165-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Penicillin G Syringes Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling Penicillin G 100,000/mL 10 mL Syringes because the product lacks sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Penicillin G 100,000/mL 10 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1190-2019·2019-04-24

    Sodium Bicarbonate Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Sodium Bicarbonate 8.4% Injection vials due to a lack of sterility assurance.

    Product
    Sodium Bicarbonate 8.4% Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1199-2019·2019-04-24

    Phenol Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Phenol 10% Injection due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Phenol 10% Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1145-2019·2019-04-24

    Gentamicin Irrigation Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Gentamicin 250 mg/1000 mL Irrigation due to a lack of sterility assurance. The recall covers 4 bottles distributed nationwide.

    Product
    Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1141-2019·2019-04-24

    Dexamethasone Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Dexamethasone 24 mg/mL Injection vials due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Dexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy, 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1136-2019·2019-04-24

    FDA Recalls Volumex Injection Due to Sterility Concerns

    Iso-Tex Diagnostics is recalling 54 syringes of Volumex (Iodinated I-131 Albumin) because environmental monitoring results indicate sterility cannot be assured.

    Product
    VOLUMEX — VOLUMEX (IODINATED I-131 ALBUMIN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1161-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Methionine Injection Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling 276 vials of a methionine and choline injection nationwide due to a lack of sterility assurance.

    Product
    Methionine 15mg/Choline 100mg/ Inositol 50mg/ Methylcobalamin 1mg/ Lidocoaine 10 mg, benzyl alcohol/ water, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1177-2019·2019-04-24

    Serum Tears 20% Drops Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Serum Tears 20% Drops due to a lack of sterility assurance. All lots of the 1 mL droptainers are affected.

    Product
    Serum Tears 20% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1152-2019·2019-04-24

    FDA Recalls HCG 20,000 Units Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling HCG 20,000 units/vial products nationwide due to a lack of sterility assurance.

    Product
    HCG 20,000 units/vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V322000·2019-04-24

    Porsche Recalls Panamera Models Due to Electrical Fire Risk

    Porsche is recalling 2010-2016 Panamera vehicles because water in the A/C blower control unit can cause an electrical short and fire.

    Product
    PORSCHE — PORSCHE PANAMERA, PANAMERA S E-HYBRID, PANAMERA S, PANAMERA 4S
    Category
    Vehicle
    Distribution
    Distributed nationwide