The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

6801–6825 of 29119

  • SevereFDA (Food)·F-0862-2022·2022-03-23

    Helmi Honey VIP Recalled for Undisclosed Drug Ingredient

    Helmi Honey VIP is being recalled nationwide due to the presence of an undisclosed drug ingredient. Consumers should stop using the product and return it.

    Product
    Helmi Honey VIP packaged in a gold paper box with black writing, 12 sachets per box UPC 3553314122014
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0866-2022·2022-03-23

    Frozen Breakfast Tarts Recalled for Undeclared Almonds

    Gourmet Kitchen, Inc. is recalling 59 boxes of 14" Raw Buttermilk Breakfast Tart with Fresh Blueberries & Granola because they contain undeclared almonds, a tree nut allergen.

    Product
    14" Raw Buttermilk Breakfast Tart with Fresh Blueberries & Granola P2006 (9 Frozen Pancakes). Barcode:0106915030162006992202425990
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0665-2022·2022-03-23

    Lorazepam 1 mg/mL Infusion Solution Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling Lorazepam 1 mg/mL Infusion Solution in 250 mL bags because the manufacturer cannot assure sterility of the product.

    Product
    Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0657-2022·2022-03-23

    Hydromorphone HCl 1 mg/mL 250 mL Bags Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling four bags of Hydromorphone HCl 1 mg/mL (250 mL each) distributed in North Carolina due to lack of assurance of sterility. The affected lots have beyond-use dates of October 25–30, 2020.

    Product
    Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0865-2022·2022-03-23

    Frozen Breakfast Tarts Recalled Due to Undeclared Almonds

    Gourmet Kitchen, Inc. is recalling 43 boxes of Raw Buttermilk Breakfast Tarts due to undeclared almonds. Consumers allergic to almonds should not consume this product.

    Product
    14" Raw Buttermilk Breakfast Tart with Cranberries, Apples & Granola P2004 (9 Frozen Pancakes). Barcode: 0106915030162004992201921137
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-0864-2022·2022-03-23

    Albanese Dark Chocolate Espresso Beans recalled due to undeclared peanut allergen

    Albanese Confectionery is recalling specific lots of its Dark Chocolate Espresso Bean tubs due to undeclared peanut allergen. Consumers with peanut allergies who purchased this product should not consume it.

    Product
    Albanese Dark Chocolate Espresso Bean packaged into 9oz plastic tubs 12 tubs per case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0667-2022·2022-03-23

    Fentanyl Infusion Solution Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling one lot of Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags because the manufacturer cannot assure the product's sterility.

    Product
    Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0861-2022·2022-03-23

    Jaguar Power Honey Recalled Nationwide for Hidden Drug Ingredient

    Jaguar Power Honey packaged in gold boxes is being recalled nationwide because it contains a hidden drug ingredient not listed on the label. Consumers should not consume this product.

    Product
    Jaguar Power Honey packaged in a gold paper box with black writing, 12 sachets per box UPC 3553314142227
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0719-2022·2022-03-23

    Unauthorized COVID-19 Diagnostic Test Kits Imported Without FDA Approval

    SD Biosensor's STANDARD Q COVID-19 Ag Home Test kits were illegally imported without FDA approval, clearance, or authorization. Approximately 400,000 units were distributed nationwide.

    Product
    STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0666-2022·2022-03-23

    Methylcobalamin Injectable Recalled Due to Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling Methylcobalamin 1 mg/mL Injectable in 1 mL syringes (Lot #07282020@3) distributed in North Carolina because the manufacturer cannot assure the product meets sterility standards.

    Product
    Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0655-2022·2022-03-23

    B. Braun 0.9% Sodium Chloride Injection bags recalled for leaking

    B. Braun Medical, Inc. is recalling 33,742 bags of 0.9% Sodium Chloride Injection USP due to leaking that compromises sterility assurance. The intravenous medication was distributed nationwide.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0863-2022·2022-03-23

    Multiple ice cream brands recalled for Listeria monocytogenes contamination

    Ice cream products manufactured by Royal Ice Cream Company in Manchester, CT are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed across multiple states under various retail and food service brand names.

    Product
    All Ice Cream and Ice Cream products within expiry; manufactured by Royal Ice Cream Company; manufactured in Manchester, CT; all effected products will have the manufacturing plant number "CT121" or "CT #121"; RETAIL BRANDS EFFECTED: Batch brand pints, all flavors; Royal Ice Crea
    Category
    Food
    Distribution
    21 states
  • SevereNHTSA·22V178000·2022-03-23

    Audi Recalls 2013-2017 Models for Turbocharger Oil Strainer Defect

    Audi is recalling 2013-2017 A8, S6, S7, S8, and RS7 vehicles because a blocked turbocharger oil strainer can cause engine failure and increase crash risk.

    Product
    AUDI — AUDI RS 7, S6, A8, S8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V176000·2022-03-23

    2022 Volkswagen Tiguan and Taos Suspension Knuckles Recalled

    Volkswagen is recalling certain 2022 and 2021 vehicles because rear suspension knuckles may corrode, crack, and break, potentially causing loss of stability and increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN TIGUAN, TAOS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0659-2022·2022-03-23

    Hydromorphone HCl Infusion Recall Due to Sterility Assurance

    Family Pharmacy of Statesville is recalling one lot of Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags due to lack of assurance of sterility.

    Product
    Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0725-2022·2022-03-23

    Avaphinal Maximum Male Enhancement Pills Recalled for Undeclared Drug

    Walmart is recalling Avaphinal Maximum Male Enhancement Sexual Pills (2000 MG, 10-capsule cartons, Lot DK1027) distributed nationwide because they contain undeclared sildenafil, making them an unapproved drug.

    Product
    Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0656-2022·2022-03-23

    Hydromorphone HCl Infusion Bags Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling Hydromorphone HCl 2 mg/mL Infusion 250 mL bags (2 units) distributed in North Carolina due to lack of assurance of sterility.

    Product
    Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0664-2022·2022-03-23

    Ketamine 50 mg Infusion Solution Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling three bags of Ketamine 50 mg Infusion Solution because the manufacturer cannot assure sterility of the product.

    Product
    Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0663-2022·2022-03-23

    Morphine Sulfate Infusion Recall Due to Sterility Assurance Failure

    Family Pharmacy of Statesville is recalling Morphine Sulfate 6 mg/mL infusions in 250 mL bags due to lack of assurance of sterility. The affected product was distributed in North Carolina.

    Product
    Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0661-2022·2022-03-23

    Trimix Injectable Vials Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling Trimix (Alprostadil/Papaverine/Phentolamine) injectable vials distributed in North Carolina due to lack of assurance of sterility.

    Product
    Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0662-2022·2022-03-23

    Vancomycin Ophthalmic Solution Recalled Due to Sterility Concerns

    Family Pharmacy of Statesville is recalling Vancomycin 14 mg/mL Fortified Ophthalmic Solution due to lack of assurance of sterility. The affected lot was distributed in North Carolina.

    Product
    Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0658-2022·2022-03-23

    Hydromorphone HCl 5 mg/mL Infusion Recall Due to Sterility Assurance

    Family Pharmacy of Statesville is recalling Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags because the manufacturer cannot assure the product meets sterility requirements.

    Product
    Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·22V168000·2022-03-18

    Mercedes-Benz Recalls Vehicles for Software Configuration Errors

    Mercedes-Benz is recalling specific 2007-2014 models because incorrect software updates may cause loss of drive power or control functions, increasing crash risk.

    Product
    MERCEDES BENZ — MERCEDES BENZ, MERCEDES-BENZ C350, SLK280, E350, G550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V166000·2022-03-17

    Newmar motorhomes recalled for loose steering column bolt

    Newmar is recalling 1,277 of its 2021 and 2022 motorhomes because the steering column bolt may not be properly tightened, potentially causing loss of steering control. Owners should contact dealers for free inspection and tightening.

    Product
    NEWMAR — NEWMAR NEW AIRE, DUTCH STAR, LONDON AIRE, KOUNTRY STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·22734·2022-03-17

    ToolGuards Portable Water Immersion Heaters Recalled for Shock and Fire Hazards

    FXswede AB is recalling about 5,000 ToolGuards Portable Water Immersion Heaters sold on Amazon.com because the units can overheat, melt, or catch fire, creating electrocution and fire hazards. The firm has received 19 reports of overheating or fires and 2 reports of consumer shock.

    Product
    ToolGuards Portable Water Immersion Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide