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.

11526–11550 of 29163

  • SevereFDA (Drugs)·D-1796-2019·2019-08-21

    Infusion Options Recalls ORENCIA Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling ORENCIA 750 mg IV infusions in New York due to a lack of assurance of sterility.

    Product
    ORENCIA 750 mg QS 100 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1789-2019·2019-08-21

    Infusion Options Recalls Leucovorin Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Leucovorin intravenous infusion bags due to a lack of assurance of sterility. The products were distributed in New York.

    Product
    LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCOVORIN 300 MG / 50 ml D5W IVPB; LEUCOVORIN 840 MG / 250 ml NS IVPB; LEUCOVORIN 750 MG / 250 ml NS IVPB; LEUCOVORIN 690 MG / 250 ml NS IVPB; LEUCOVORIN 314 mg / 50 ml NS IVPB; LEUCOVORIN 620 MG / 250 ml…
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·19V617000·2019-08-21

    Volvo Recalls 2015 VNL Trucks for Front Axle Fracture Risk

    Volvo Trucks North America is recalling 2015 VNL trucks because front axles may fracture due to missed heat treating, increasing crash risk.

    Product
    VOLVO — VOLVO VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1767-2019·2019-08-21

    Infusion Options Recalls Dexamethasone Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling specific dexamethasone infusion products in New York due to a lack of assurance of sterility.

    Product
    DEXAMETHASONE 10 MG / 50 ML NS IVPB; DEXAMETHASONE 5 MG / 50 ML NS; DEXAMETHASONE 5 MG / 50 ML NS IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1754-2019·2019-08-21

    Bortezomib Syringes Recalled for Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Bortezomib subcutaneous syringes in New York due to a lack of assurance of sterility.

    Product
    BORTEZOMIB 2.5 mg / 1 ML SQ SYRINGE; BORTEZOMIB 2.88 MG / 1.15 ML SQ SYRINGE; BORTEZOMIB 2.31 MG / 0.92 ml SQ SYRINGE; BORTEZOMIB 2.7 mg / 1.08 ML SQ SYRINGE; BORTEZOMIB 1.45 mg / 0.58 ml SQ SYRINGE; BORTEZOMIB 2.25 mg (0.9 ML) SQ SYRINGE; BORTEZOMIB 1.98 mg / 0.79 ml SQ…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1802-2019·2019-08-21

    Panitumumab Infusion Recalled Due to Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Panitumumab 400 mg/100 mL IV products in New York due to a lack of assurance of sterility.

    Product
    PANITUMUMAB 400 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1760-2019·2019-08-21

    Infusion Options Recalls Cisplatin Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Cisplatin infusion products due to a lack of assurance of sterility. The recall is limited to New York.

    Product
    Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL; Cisplatin 44 MG QS 500 ml NS IVPB; Cisplatin 40 MG / 500 ml 0.9% NACL; Cisplatin 36 MG / 500 ML NS IVPB; Cisplatin 73 MG QS 500 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 70 MG / 500 ml NS…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1755-2019·2019-08-21

    Infusion Options Recalls Calcium Glucunate IV Bags Due to Sterility Concerns

    Infusion Options, Inc. is recalling Calcium Glucunate 1 gm/100 mL IV bags in New York due to a lack of assurance of sterility.

    Product
    CALCIUM GLUCONATE 1 GM /100 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1779-2019·2019-08-21

    Infusion Options Recalls Fluorouracil Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Fluorouracil infusion products in New York due to a lack of assurance of sterility.

    Product
    Fluorouracil 560 MG / 11.2 ML IVP Fluorouracil 3340 MG QS 92 ML 0.9% NACL Fluorouracil 3920 MG QS 92 ML 0.9% NACL Fluorouracil 3760 mg QS 100 ml NS CASS Fluorouracil 4000 MG QS 92 ml 0.9% NACL Fluorouracil 3140 MG QS 240 ML NS PUMP Fluorouracil 2400 MG QS 96 ML 0.9% NACL…
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·19V609000·2019-08-20

    Thor Motor Coach Recalls 2020 Motorhomes for Battery Cable Fire Risk

    Thor Motor Coach is recalling 1,941 2020 motorhomes because loose battery cables may cause electrical arcing and increase the risk of a fire.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH, THOR MAJESTIC, DAYBREAK, CHATEAU, OUTLAW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V606000·2019-08-16

    Kenworth T270 and T370 Recalled for Brake Hose Separation Risk

    PACCAR is recalling 2020 Kenworth T270 and T370 trucks because loose fittings may cause the brake air hose to separate, reducing braking ability.

    Product
    KENWORTH — KENWORTH T270, T370
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·084-2019·2019-08-15

    Tyson Recalls Weaver Chicken Patties Due to Foreign Matter Contamination

    Tyson Foods is recalling approximately 39,078 pounds of Weaver brand frozen chicken patties due to possible foreign matter contamination. Consumers should not consume these products.

    Product
    Tyson Foods, Inc. — Tyson Foods, Inc. Recalls Weaver Brand Ready-To-Eat Chicken Patty Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E054000·2019-08-15

    Capco Recalls CTR Outer Tie Rods Due to Durability Concerns

    Capco USA is recalling CTR Outer Tie Rods because the taper on the ball studs may affect durability. This defect could impact vehicle control and increase crash risk.

    Product
    STEERING:LINKAGES:TIE ROD ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V602000·2019-08-15

    Altec Recalls Aerial Devices Due to Winch Valve Defect

    Altec is recalling 2012-2019 aerial devices because a winch valve defect may allow lifting beyond rated capacity, increasing injury risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1691-2019·2019-08-14

    RXQ Compounding Recalls Ondansetron Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Ondansetron 2 mg/mL Injection Solution because the product lacks assurance of sterility.

    Product
    ONDANSETRON 2 MG/ML INJECTION SOLUTION (PFV), 2 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0158-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2085-2019·2019-08-14

    Williams Original Chili Seasoning Recalled for Potential Salmonella Contamination

    CH Guenther & Sons, Inc. is recalling Williams Original Chili Seasoning because it contains cumin potentially contaminated with Salmonella.

    Product
    Williams Original Chili Seasoning, Net Wt. 1 OZ, Williams Foods, Inc. Lenexa, KS, UPC 0 41149 01100 7
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Drugs)·D-1668-2019·2019-08-14

    RXQ Compounding Recalls Inositol/Choline B12:B6 Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Inositol/Choline B12:B6 injection solution because there is a lack of assurance of sterility.

    Product
    Inositol/Choline B12:B6, 50/50/1/0.175 MG/ML INJ SOLN(Sulfa Free Lipostat), 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0999-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2073-2019·2019-08-14

    St Jude Medical Recalls 21 Ellipse DR Implantable Cardioverter Defibrillators

    St Jude Medical is recalling 21 Ellipse DR implantable cardioverter defibrillators due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.

    Product
    ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1666-2019·2019-08-14

    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. The recall covers all lots within expiry distributed nationwide.

    Product
    HYDROXOCOBALAMIN 1000 MCG/ML (PFV), 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0949-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1704-2019·2019-08-14

    RXQ Compounding Recalls Sodium Bicarbonate Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Sodium Bicarbonate 8.4% Injection due to a lack of assurance of sterility. The product is distributed nationwide.

    Product
    SODIUM BICARBONATE 8.4% (1 MEQ/ML) INJ SOLN (PFV), 50 ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0957-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1680-2019·2019-08-14

    RXQ Compounding Recalls MIC Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling MIC (Methionine/Inositol/Choline Chloride) 25/50/50 mg/mL Injection due to a lack of assurance of sterility.

    Product
    MIC (METHIONINE/INOSITOL/CHOLINE CHLORIDE) 25/50/50 MG/ML INJ, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0100-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1638-2019·2019-08-14

    RXQ Compounding Recalls Buffered Lidocaine Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Buffered Lidocaine 1%+Epi 1:100,000 Injection Solution because the product lacks assurance of sterility.

    Product
    BUFFERED LIDOCAINE 1%+EPI 1:100,000 INJ SOL, [3ML NDC: 70731-0137-03 and 30ML NDC: 70731-0137-30] per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0137-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1673-2019·2019-08-14

    RXQ Compounding Recalls Magnesium, Calcium, and Zinc Vials for Sterility Concerns

    RXQ Compounding LLC is recalling magnesium, calcium, and zinc vials due to a lack of assurance of sterility. The products were distributed nationwide.

    Product
    MAGNESIUM 200 MG/ML/ CALCIUM GLUC 6MG/ML/ ZINC 1MG/ML, 5ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0176-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1649-2019·2019-08-14

    RXQ Compounding Recalls DMPS Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Dimercapto-Propanesulfonic 5% (DMPS) injection solution because the product lacks assurance of sterility.

    Product
    DIMERCAPTO-PROPANESULFONIC 5% (DMPS)( (PFV) INJ SOL, 5 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0904-05
    Category
    Drug
    Distribution
    Distributed nationwide