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.

11576–11600 of 29163

  • SevereFDA (Drugs)·D-1641-2019·2019-08-14

    RXQ Compounding Recalls Calcium Chloride Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Calcium Chloride 100mg/mL Injection Solution because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    CALCIUM CHLORIDE 100MG/ML (PFV) INJ SOLN, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0920-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1699-2019·2019-08-14

    RXQ Compounding Recalls Pyridoxine Vials Due to Sterility Concerns

    RXQ Compounding LLC is recalling Pyridoxine (MDV) 100mg/mL vials because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    PYRIDOXINE (MDV) 100MG/ML, 30ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0956-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1705-2019·2019-08-14

    RXQ Compounding Recalls Lidocaine Syringes Due to Sterility Concerns

    RXQ Compounding LLC is recalling Lidocaine 0.75%/Epinephrine 0.025% syringes because the FDA determined there is a lack of assurance of sterility.

    Product
    LIDOCAINE 0.75%/Epinephrine 0.025%/BSS 0.56ML SYR, 1 ML PER Syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0919-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1682-2019·2019-08-14

    RXQ Compounding Recalls Midazolam Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Midazolam 1mg/mL injection syringes because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SOL SYR (C-IV), 10 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0135-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1651-2019·2019-08-14

    RXQ Compounding Recalls EDETATE DISODIUM 30% INJECTABLE Due to Sterility Concerns

    RXQ Compounding LLC is recalling EDETATE DISODIUM 30% INJECTABLE, 100 ML vials, because the product lacks assurance of sterility.

    Product
    EDETATE DISODIUM 30% INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0931-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1662-2019·2019-08-14

    RXQ Compounding Recalls Glutathione Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Glutathione 200mg/ml Injection Solution because the product lacks assurance of sterility. All lots within expiry are affected nationwide.

    Product
    GLUTATHIONE 200MG/ML (PFV) INJECTION SOLN, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0971-81
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1714-2019·2019-08-14

    RXQ Compounding Recalls TURBO DROPS Ophthalmic Solution Due to Sterility Concerns

    RXQ Compounding LLC is recalling TURBO DROPS ophthalmic solution because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    TURBO DROPS (PHEN 10% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per dropper bottle, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0206-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1667-2019·2019-08-14

    RXQ Compounding Recalls Hydroxocobalamin Injections Due to Sterility Concerns

    RXQ Compounding LLC is recalling Hydroxocobalamin 1000 mcg/mL injections because the product lacks assurance of sterility.

    Product
    HYDROXOCOBALAMIN 1000 MCG/ML (MDV), 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0926-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1981-2019·2019-08-14

    Deep Golden Raisins Recalled for Undeclared Sulfites

    Deep Foods Inc. is recalling Deep Golden Raisins in 7 oz, 14 oz, and 28 oz packages due to undeclared sulfites.

    Product
    "DEEP***GOLDEN RAISINS***NET WT***198g/7oz***DEEP FOODS, INC. UNION, NJ 07083"
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2204-2019·2019-08-14

    Ad-Tech Recalls Non-Sterile Anchor Bolts for Depth Electrodes

    Ad-Tech Medical Instrument Corporation is recalling 201 non-sterile anchor bolts distributed without regulatory clearance or validated sterilization instructions.

    Product
    LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 13mm non-anodized anchor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V593000·2019-08-14

    BMW Recalls G310R, G310 GS, and C 400 X for Brake Caliper Defect

    BMW is recalling 2017-2020 G310R, 2018-2020 G310 GS, and 2019 C 400 X motorcycles because brake caliper pistons may corrode and stick, increasing crash risk.

    Product
    BMW — BMW G310R, G310 GS, C 400 X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1650-2019·2019-08-14

    RXQ Compounding Recalls EDETATE CALCIUM DISODIUM INJECTABLE Due to Sterility Concerns

    RXQ Compounding LLC is recalling EDETATE CALCIUM DISODIUM 150MG/ML INJECTABLE vials because the product lacks assurance of sterility.

    Product
    EDETATE CALCIUM DISODIUM 150MG/ML INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0934-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V601000·2019-08-14

    BMW and MINI Recall Vehicles Due to Steering Tie Rod Defect

    BMW is recalling 2018-2019 X1, X2, and MINI Cooper models because incorrectly assembled steering tie rods may break, causing loss of vehicle control.

    Product
    BMW — BMW, MINI X1, X2, COOPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1646-2019·2019-08-14

    RXQ Compounding Recalls Dextrose 50% Injection Syringes Due to Sterility Concerns

    RXQ Compounding LLC is recalling Dextrose 50% Injection Solution syringes because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    DEXTROSE 50% INJECTION SOLUTION (PF) SYRINGE, 50 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0969-89
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1640-2019·2019-08-14

    RXQ Compounding Recalls Buffered Lidocaine HCL 1% Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Buffered Lidocaine HCL 1% Injection Solution because the product lacks assurance of sterility.

    Product
    BUFFERED LIDOCAINE HCL 1% INJECTION SOL (PF) SYR, 0.5 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0139-84
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1672-2019·2019-08-14

    RXQ Compounding Recalls Lidocaine HCL 2% Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Lidocaine HCL 2% Injection Solution because the product lacks assurance of sterility. The recall covers all lots within their expiry dates.

    Product
    LIDOCAINE HCL 2% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0172-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1710-2019·2019-08-14

    RXQ Compounding Recalls Thiamine HCL Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Thiamine HCL 100mg/mL Injection because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    THIAMINE HCL 100MG/ML (MDV) INJECTION, 10 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0950-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1647-2019·2019-08-14

    RXQ Compounding Recalls Dextrose 50% Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Dextrose 50% Injection Solution vials because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    DEXTROSE 50% INJECTION SOLUTION (PF) VIAL, 50 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0969-89
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1676-2019·2019-08-14

    RXQ Compounding Recalls Manganese Sulfate Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Manganese Sulfate Monohydrate Injection because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    MANGANESE SULFATE MONOHYDRATE (PFV) 0.1MG/ML INJ, 10 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0952-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1694-2019·2019-08-14

    RXQ Compounding Recalls Potassium Chloride Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Potassium Chloride 15% Injection Solution due to a lack of assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    POTASSIUM CHLORIDE 15% (2MEQ/ML) INJ SOLN, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0954-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1657-2019·2019-08-14

    RXQ Compounding Recalls Epinephrine Syringes Due to Sterility Concerns

    RXQ Compounding LLC is recalling Epinephrine 1:1000 Injection Solution syringes because the company cannot ensure the product is sterile.

    Product
    EPINEPHrine 1:1000 INJECTION SOLUTION (PF) Syringe, 1 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0947-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2168-2019·2019-08-14

    Centurion Medical Recalls High Drainage LVAD Tray Kits Due to Packaging Concerns

    Centurion Medical Products Corporation is recalling 192 High Drainage LVAD Tray Kits because sterile packaging may be compromised.

    Product
    HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1685-2019·2019-08-14

    RXQ Compounding Recalls Molybdenum Injection Solution Due to Sterility Concerns

    RXQ Compounding LLC is recalling Molybdenum 0.025mg/mL Injection Solution because the product lacks assurance of sterility.

    Product
    MOLYBDENUM 0.025MG/ML INJECTION SOLUTION, 10ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0964-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1656-2019·2019-08-14

    RXQ Compounding Recalls Epinephrine Infusion Bags Due to Sterility Concerns

    RXQ Compounding LLC is recalling Epinephrine 4mg in D5W 5% infusion bags because the agency could not ensure the product was sterile.

    Product
    EPINEPHrine 4MG ADDED TO D5W 5%, 250 ML per bag, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0113-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1718-2019·2019-08-14

    RXQ Compounding Recalls Zinc Sulfate Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Zinc Sulfate 1mg/mL Injection Solution because the product lacks assurance of sterility.

    Product
    ZINC SULFATE 1MG/ML INJECTION SOLUTION (PFV), 10ML per VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0963-10
    Category
    Drug
    Distribution
    Distributed nationwide