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.

4476–4500 of 4878

  • SevereFDA (Food)·F-0072-2022·2021-11-03

    Nature's Heart Toasted Coconut Chips recalled for undeclared peanuts

    Nestle USA is recalling Nature's Heart Toasted Coconut Chips 1.5oz pouches because they contain undeclared peanuts, posing a serious risk to consumers with peanut allergies.

    Product
    Nature's Heart Toasted Coconut Chips 1.5oz poly film pouches - 32 units per case
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Drugs)·D-0040-2022·2021-11-03

    Levocarnitine Injectable Solution Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling levocarnitine 100 mg/mL injectable solution (all lots within expiry) due to FDA inspection findings that raised sterility assurance concerns. Approximately 494 patients in seven states received prescriptions.

    Product
    LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0063-2022·2021-11-03

    MIC/B12A Injectable Compounded Drug Recall for Sterility Assurance

    Red Mountain Compounding Pharmacy is recalling MIC/B12A 25/50/50MG/ML 1MG/ML MDV injectable medication because FDA inspection found the firm could not guarantee the sterility of the product. Approximately 494 patients across seven states received prescriptions for this medication.

    Product
    MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0039-2022·2021-11-03

    Hydroxyprogesterone Caproate Injection Recalled Due to Sterility Concerns

    First Royal Care Compounding Pharmacy is recalling Hydroxyprogesterone Caproate 250 mg/mL oil injection due to lack of assurance of sterility identified during FDA inspection. The drug was distributed to patients in seven states.

    Product
    HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0066-2022·2021-11-03

    Progesterone 100mg/ml Oil Injection Recall: Sterility Assurance Defect

    Red Mountain Compounding Pharmacy is recalling Progesterone 100mg/ml MDV Oil Injection due to lack of assurance of sterility following FDA inspection. About 494 patients in seven states received prescriptions for this affected product.

    Product
    PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Food)·F-0071-2022·2021-11-03

    Nature's Heart Superfood Trail Mix recalled for undeclared peanuts

    Nestle USA is recalling Nature's Heart Superfood Trail Mix 1.5oz pouches because they contain undeclared peanuts, posing a serious risk to consumers with peanut allergies.

    Product
    Nature's Heart Superfood Trail Mix 1.5oz poly film pouches - 32 units per case
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Drugs)·D-0030-2022·2021-11-03

    Levocarnitine 100mg/mL Solution Recall Due to Sterility Assurance

    Red Mountain Compounding Pharmacy is recalling Levocarnitine 100mg/mL solution for injection because FDA inspection found concerns about the product's sterility assurance. The product was distributed to patients in seven states.

    Product
    LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0037-2022·2021-11-03

    Estradiol Valerate Injection Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling Estradiol Valerate 5mg/mL injectable medication due to FDA inspection findings of inadequate sterility assurance. The product was distributed to approximately 494 patients across seven states.

    Product
    ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0057-2022·2021-11-03

    Folic Acid 10mg/mL Injectable Recalled Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling folic acid injectable medication because the FDA found the product lacks adequate sterility assurance. The recall affects prescriptions distributed across multiple states.

    Product
    FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereNHTSA·20V175000·2021-11-03

    2021 Ford E-350 and E-450 wire harness may damage fuel pump and ABS

    Ford is recalling 2021 E-350 and E-450 vehicles because a rear wire harness may contact the frame and damage circuits for the fuel pump and anti-lock braking system, potentially causing engine stall or loss of braking control.

    Product
    FORD — 2021 FORD E-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0035-2022·2021-11-03

    Cyclosporine 2% MCT Oil Suspension Recalled for Sterility Assurance

    Red Mountain Compounding Pharmacy is recalling Cyclosporine 2% MCT Oil Suspension due to FDA inspection findings of sterility assurance concerns. Approximately 494 patients in seven states received prescriptions for this medication.

    Product
    CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0065-2022·2021-11-03

    MIT/B12 Compounded Injection Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling MIT/B12 25/50/50MG/ML 1MG/ML multidose vials due to FDA inspection findings that raised concerns about the lack of assurance of sterility. The product was distributed to approximately 494 patients across seven states.

    Product
    MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0061-2022·2021-11-03

    Methylcobalamin Injection Recalled for Sterility Assurance Deficiency

    Red Mountain Compounding Pharmacy is recalling Methylcobalamin 5000 mcg/mL multi-dose vial injection due to lack of assurance of sterility identified during FDA inspection. The product was distributed to approximately 494 patients in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah.

    Product
    METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0038-2022·2021-11-03

    Glutathione 200mg/mL MDV Recalled Due to Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling Glutathione 200mg/mL MDV (multiple-dose vials) because FDA inspection identified concerns that the product may lack proper sterility assurance. The product was distributed to patients in multiple states.

    Product
    GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Food)·F-0074-2022·2021-11-03

    Nature's Heart Mango Turmeric Cashew Mix Recalled for Undeclared Peanuts

    Nestle USA Inc. is recalling Nature's Heart Mango Turmeric Cashew Glazed Mix 1.5oz pouches due to undeclared peanut allergen. The product was distributed across 32 states.

    Product
    Nature's Heart Mango Turmeric Cashew Glazed Mix 1.5oz poly film pouches - 32 units per case
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Drugs)·D-0042-2022·2021-11-03

    Red Mountain Compounding Test Cypionate Sterility Assurance Recall

    Red Mountain Compounding Pharmacy is recalling Test Cypionate 100MG/ML in Ethyl Oleate Oil due to FDA inspection findings of sterility assurance concerns.

    Product
    TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Food)·F-0068-2022·2021-11-03

    Fullei Fresh Bean and Soy Sprouts Recalled for Listeria Risk

    Kwokcheng Enterprise, Inc. dba Fullei Fresh is voluntarily recalling all lots of refrigerated bean and soy sprouts distributed in Florida due to potential Listeria monocytogenes contamination.

    Product
    All products are stored refrigerated and labeled with Fullei Fresh brand. 10 lb Bean Sprouts in cardboard box; 5 lb Bean Sprouts in cardboard box; 8 bags of 8 oz Bean Sprout Pouches (Pouched then placed in cardboard box); 8 bags of 4 oz Organic Bean Sprouts (in plastic clams
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0031-2022·2021-11-03

    Ascorbic Acid Solution Recalled Due to Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling Ascorbic Acid (Non-Corn) 500mg/mL multi-dose solution due to FDA inspection findings regarding lack of sterility assurance. The affected product was distributed to approximately 494 patients across seven states.

    Product
    ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0059-2022·2021-11-03

    Methylcobalamin Injectable: Sterility Assurance Deficiency

    Red Mountain Compounding Pharmacy is recalling methylcobalamin 1000 mcg/mL injectable due to FDA inspection findings that raised concerns about the product's sterility assurance.

    Product
    METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0058-2022·2021-11-03

    Methylcobalamin Injectable Recalled Due to Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling methylcobalamin 10,000 MCG/ML multi-dose vials after FDA inspection identified sterility assurance concerns.

    Product
    METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Food)·F-0073-2022·2021-11-03

    Nature's Heart Pineapple Chili Cashew Mix Recalled for Undeclared Peanuts

    Nestle USA is recalling Nature's Heart Pineapple Chili Cashew Glazed Mix due to undeclared peanut allergen. The product was distributed across 32 states, and consumers with peanut allergies should not consume it.

    Product
    Nature's Heart Pineapple Chili Cashew Glazed Mix 1.5oz poly film pouches - 32 units per case
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Drugs)·D-0047-2022·2021-11-03

    TEST CYP/PROP Compounded Injection Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling TEST CYP/PROP 160/40MG/ML MDV in ethyl oleate due to FDA inspection findings that raised concerns about sterility assurance. Approximately 494 patients in multiple states received affected prescriptions.

    Product
    TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0011-2022·2021-10-27

    Coppertone Pure & Simple Kids 50 Sunscreen Spray Recalled for Benzene Contamination

    Beiersdorf Inc. is recalling Coppertone Pure & Simple kids 50 Sunscreen Spray due to the presence of benzene, a chemical contaminant. The affected product was distributed nationwide.

    Product
    Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0055-2022·2021-10-27

    Roasted Salted Cashew Halves and Pieces recalled for glass contamination

    Suntree Snack Foods is recalling Roasted Salted Cashew Halves and Pieces due to the presence of glass pieces in the product. The recall affects 960 cases distributed across multiple states.

    Product
    Roasted Salted Cashew Halves and Pieces, 8 oz. , UPC 072036734891. 8 bags/case.
    Category
    Food
    Distribution
    11 states