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.

9151–9175 of 29156

  • SevereFDA (Food)·F-1529-2020·2020-09-30

    Frito-Lay Classic Cube Mix Recalled for Undeclared Milk

    Frito-Lay is recalling 28-count Classic Cube Mix boxes because they may contain undeclared milk. The product was distributed to retail and foodservice channels in 11 western states.

    Product
    Frito-Lay 28 count Classic Cube Mix cube box UPC 28400 15586 1 oz. individual bags packaged in a larger non-flexible box
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Devices)·Z-3005-2020·2020-09-30

    Siemens Syngo.via RT Image Suite Software Recall for Calibration Offset Error

    Siemens is recalling Syngo.via RT Image Suite software due to a calibration offset error that could result in incorrect radiation dose or dose applied to the wrong location.

    Product
    Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1623-2020·2020-09-30

    Preferred Pharmaceuticals Recalls Nature-Throid Tablets Due to CGMP Deviations

    Preferred Pharmaceuticals is voluntarily recalling specific lots of Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The affected repackaged tablets were sold to three physicians in California and Georgia.

    Product
    Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg, packaged in a) 90-count bottles (NDC 68788-7604-09), b) 100-count tablets (NDC 68788-7604-01), Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1593-2020·2020-09-30

    Zanilast+ Gel Antiseptic Hand Sanitizer Recalled for Potential 1-Propanol Contamination

    Nanomateriales S.A. de C.V. is recalling 1,000 kg of Zanilast+ Gel Antiseptic Hand Sanitizer due to GMP deviations that may result in the presence of 1-propanol.

    Product
    Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in 25 kg bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Caracol, 64810, Monterrey, N.L., Mexico Nanomateriales S.A. DE C.V. NDC 69912-006-01
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1586-2020·2020-09-30

    Leafree Hand Sanitizer Recalled for Lacking FDA Approval

    Corgiomed LLC is recalling Leafree Instant Hand Sanitizer because it was marketed without FDA approval and labeled as edible alcohol.

    Product
    Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 6970495860325, b) 300 mL bottles, UPC code 6970495860318, and c) 500 mL bottles, UPC code 6970495860301, Exclusively Distributed by: Corgiomed LLC, Mc
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-1544-2020·2020-09-30

    Gilster-Mary Lee Recalls Organic Microwave Popcorn Due to Glass Contamination

    Gilster-Mary Lee Corp. is recalling specific brands of organic microwave popcorn because tempered glass pieces were found in the product.

    Product
    Microwave popcorn packaged in the following ways: 1) Full Circle Organic Microwave Popcorn Salted, 3-2.9 oz (82 g) bags, Net Wt. 8.7 oz (247 g), Distributed by Topco Associates LLC, Elk Grove Villiage, IL, UPC 36800-40611 2) Sprouts Farmers Market, Organic Salted Microwave
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Devices)·Z-2941-2020·2020-09-30

    MicroPort Recalls PROFEMUR Titanium Hip Prosthesis Components Due to Fracture Reports

    MicroPort Orthopedics is recalling specific PROFEMUR Titanium hip prosthesis components due to reports of fractures after implantation.

    Product
    PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
    Category
    Medical Device
    Distribution
    0 states
  • SevereCPSC·20193·2020-09-30

    STIHL Recalls Mini-Cultivator Attachments Due to Laceration Hazard

    STIHL is recalling about 185,000 mini-cultivator attachments because the gearbox may be installed upside down, causing tines to rotate toward the operator and posing a laceration risk.

    Product
    STIHL BF-KM Mini-Cultivator attachments
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V595000·2020-09-29

    Mercedes-Benz and Freightliner Sprinter Fuel Line Clamp Recall

    Daimler Vans USA is recalling 2019-2020 Sprinter vans because fuel line clamps may loosen, causing a fuel leak that increases fire risk.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 2500, SPRINTER 3500, SPRINTER 4500, SPRINTER 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V593000·2020-09-28

    Kenworth T680 Trucks Recalled for Brake System Valve Defect

    PACCAR is recalling 2016-2021 Kenworth T680 trucks because a brake valve defect may increase stopping distance and crash risk.

    Product
    KENWORTH — KENWORTH T680
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V592000·2020-09-28

    Shyft Recalls 2015-2019 Utilimaster Ram ProMaster Fleet Vehicles

    Shyft Group is recalling 2015-2019 Utilimaster Ram ProMaster fleet vehicles because the transmission shifter cable may disconnect, causing unintended vehicle movement.

    Product
    UTILIMASTER — UTILIMASTER RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V587000·2020-09-24

    Altec Recalls 2019-2020 Aerial Devices and Digger Derricks for Bolt Failure

    Altec is recalling 280 units of 2019-2020 aerial devices and digger derricks because bolts securing the pedestal to the turntable may fail, posing a risk of injury or death.

    Product
    ALTEC — ALTEC DIGGER DERRICK, AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E071000·2020-09-24

    Dometic Recalls 3-Burner Cooking Stoves Due to Gas Leak Risk

    Dometic is recalling specific 3-burner cooking stoves because a saddle valve bolt may be overtightened, damaging the seal and causing a gas leak that increases fire risk.

    Product
    EQUIPMENT:APPLIANCE:OVEN/STOVE/COOKTOP recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V580000·2020-09-24

    Chrysler Recalls Jeep and Ram Vehicles for Front Seat Belt Retractor Defect

    Chrysler is recalling specific 2019-2020 Jeep and Ram vehicles because front seat belt retractors may not properly slow occupants in a crash, increasing injury risk.

    Product
    JEEP — JEEP, RAM GLADIATOR, 2500, WRANGLER, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1579-2020·2020-09-23

    Scent Theory Hand Sanitizer Recalled for Methanol Contamination

    Scent Theory KEEP IT CLEAN hand sanitizer is being recalled because it was manufactured in a facility where methanol contamination was found.

    Product
    scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL, Distributed by Scent Theory Products, LLC New York, NY 10018, Made in Mexico, UPC 8 40038 21434 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1607-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets because they were manufactured under conditions found to be subpotent.

    Product
    WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5550-2 ; b) 30 Tablets, NDC 64727-5550-4; c) 60 Tablets, NDC 64727-5550-5; d) 90 Tablets, NDC 64727-5550-6; e) 100 Tablets, NDC 64727-5550-1; Rx only, Manufactured by: RLC Labs Pho
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1606-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The products were manufactured under conditions found to be subpotent.

    Product
    WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg], 1/4 Grain (16.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-5450-4; b) 60-count bottles, NDC 64727-5450-5; c) 90-count bottles, NDC 64727-5450-6; d) 100-count bottle
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E064000·2020-09-23

    Volkswagen Master Cylinders Recalled for Brake Fluid Leak Risk

    Tenneco is recalling aftermarket master cylinders for 2004-2018 Jetta and 2012-2019 Beetle vehicles due to a seal defect that may cause brake fluid leaks and reduced braking ability.

    Product
    VOLKSWAGEN — VOLKSWAGEN BEETLE, JETTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1611-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets because they were manufactured under conditions associated with subpotent products.

    Product
    WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5850-2 ; b) 30 Tablets, NDC 64727-5850-4; c) 60 Tablets, NDC 64727-5850-5; d) 90 Tablets, NDC 64727-5850-6; e) 100 Tablets, NDC 64727-5850-1; Rx only, Manufactured by: RLC Labs P
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1608-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets because they were manufactured under conditions associated with subpotent products.

    Product
    WP Thyroid, Westhroid Pure, 3/4 Grain (48.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5650-2 ; b) 30 Tablets, NDC 64727-5650-4; c) 60 Tablets, NDC 64727-5650-5; d) 90 Tablets, NDC 64727-5650-6; e) 100 Tablets, NDC 64727-5650-1; Rx only, Manufactured by: RLC Labs
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1616-2020·2020-09-23

    RLC Labs Recalls Subpotent Nature Throid Thyroid Medication

    RLC Labs Inc. is recalling Nature Throid thyroid medication because FDA analysis found the product to be subpotent.

    Product
    Nature Throid, 3/4 Grain (48.75 mg) Thyroid USP [Liothyronine (T3) 6.75 mcg, Levothyroxine (T4) 28.5 mcg], packaged in a) 100-count bottles (NDC 64727-3302-1) and b) 1000-count bottles (NDC 64727-3302-2), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034
    Category
    Drug
    Distribution
    Distributed nationwide