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.

7651–7675 of 29121

  • 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-0048-2022·2021-11-03

    Compounded Anabolic Steroid Product Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling a compounded anabolic steroid product due to FDA concerns about sterility assurance identified during inspection. The product was distributed to approximately 494 patients in seven states.

    Product
    TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0053-2022·2021-11-03

    Acetylcysteine 10% ophthalmic solution recalled for sterility assurance concerns

    Red Mountain Compounding Pharmacy is recalling Acetylcysteine 10% ophthalmic solution due to lack of sterility assurance identified during an FDA inspection. Approximately 494 patients received prescriptions for the product across seven states.

    Product
    ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 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
  • SevereNHTSA·21V854000·2021-11-03

    Mercedes-Benz Recalls One 2020 Sprinter for Incorrect Brake Discs

    Daimler Vans USA is recalling one 2020 Mercedes-Benz Sprinter because incorrect-size front brake discs may extend stopping distance and increase crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER (VS30)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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 (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
  • 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-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-0033-2022·2021-11-03

    Ascorbic/Glutathione Eye Solution Recalled for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling an ascorbic/glutathione eye solution because FDA inspection identified concerns about sterility assurance during manufacturing.

    Product
    ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 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-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 (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 (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 (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-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-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-0044-2022·2021-11-03

    TEST CYP 200MG/ML injection recalled due to sterility assurance concerns

    Red Mountain Compounding Pharmacy is recalling TEST CYP 200MG/ML MDV ETHYL OLEATE due to FDA inspection findings of lack of assurance of sterility. The product was distributed to approximately 494 patients across seven states.

    Product
    TEST CYP 200MG/ML MDV ETHYL OLEATE, 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
  • SevereNHTSA·21V850000·2021-11-02

    Thomas Built Buses Recalling 2020-2022 Models for Alternator Fire Risk

    Daimler Trucks is recalling 1,434 Thomas Built school buses because a loose alternator cable connection may cause electrical arcing and increase the risk of a fire.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX, SAF-T-LINER EFX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V849000·2021-11-01

    Heartland Cyclone and Road Warrior RVs recalled for loose electrical wires

    Heartland Recreational Vehicles is recalling 2019-2021 Road Warrior and 2020-2021 Cyclone trailers because wire securement lugs may be improperly tightened. Loose wires can cause electrical arcing and increase fire risk.

    Product
    HEARTLAND — HEARTLAND CYCLONE, ROAD WARRIOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V845000·2021-10-29

    Thor Motor Coach Recalls 2017 Outlaw, Challenger, and Miramar Motorhomes

    Thor Motor Coach is recalling 2017 Outlaw, Challenger, and Miramar motorhomes because external compartment door skins may separate during transit, creating a road hazard.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH CHALLENGER, MIRAMAR, OUTLAW
    Category
    Vehicle
    Distribution
    Distributed nationwide