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.

9176–9200 of 29156

  • SevereFDA (Food)·F-1514-2020·2020-09-23

    Wegmans Peach Shortcake Recalled Due to Salmonella Contamination Risk

    Wegmans is recalling two varieties of peach shortcake because raw peaches may be contaminated with Salmonella Enteritidis.

    Product
    Wegmans Peach Shortcake Slice; 7oz; UPC 7789051241 and Wegmans 1 Layer Peach Shortcake; 26oz; UPC: 7789051239
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-1617-2020·2020-09-23

    RLC Labs Recalls Subpotent Nature Throid Thyroid Medication

    RLC Labs Inc. is recalling Nature Throid 1.25 Grain thyroid medication because FDA analysis found the product to be subpotent.

    Product
    Nature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg, Levothyroxine (T4) 47.5 mcg], 100-count bottles, Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3303-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2975-2020·2020-09-23

    Inpeco Aptio Automation Systems Recalled for Potential Sample ID Mis-association

    Inpeco S.A. is recalling Aptio Automation systems with Sysmex Interface Modules because a firmware defect may mis-associate sample IDs, leading to incorrect or delayed clinical chemistry results.

    Product
    Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analyti
    Category
    Medical Device
    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
  • 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
  • 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-1581-2020·2020-09-23

    Born Basic Hand Sanitizer Recalled for Methanol Contamination

    The FDA is recalling Born Basic Anti-Bac Hand Sanitizer because it contained methanol and had lower ethanol levels than labeled. The recall includes other products from the same manufacturing facility.

    Product
    BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038 21462 4: b) 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3; and c) 34 FL OZ (1L) bottle, UPC 8 40038 21447 1; Made in Mexico; Distributed by Scent Theory
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1577-2020·2020-09-23

    Broncolin HERBACIL Hand Sanitizer Recalled for Methanol Contamination Risk

    Broncolin is recalling HERBACIL Antiseptic Hand Sanitizer because it was manufactured in the same facility as a product found to contain methanol.

    Product
    HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml) bottle, UPC 7 14706 91368 6; b) 8.4 fl. oz. (250 ml) bottle, UPC 714706 91367 9; c) 16.9 fl. oz. (500 ml) bottle, UPC 7 14706 91366 2; and d) 33.8 fl. oz. (1 Liter) bottle, UPC 7
    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
  • SevereNHTSA·20V576000·2020-09-23

    Ford Recalls 2019 F-250 and F-350 Trucks for Axle Weld Defect

    Ford is recalling 2019 F-250 and F-350 trucks because a front axle weld may be improper, increasing crash risk. Dealers will inspect and replace axles if needed.

    Product
    FORD — FORD redundant F-250, redundant F-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E069000·2020-09-23

    Ford Recalls Replacement Brake Pedal Brackets Due to Fracture Risk

    Ford is recalling certain replacement brake pedal brackets that may fracture during sudden stopping, potentially affecting braking ability and increasing crash risk.

    Product
    SERVICE BRAKES, HYDRAULIC:PEDALS AND LINKAGES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1601-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

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

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 15.75 mcg and levothyroxine (T4) 66.5 mcg], 1.75 Grain (113.75 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3307-4; b) 60-count bottles, NDC 64727-3307-5; c) 90-count bottles, NDC 64727-3307-6; d) 100-count bottles, NDC 64
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2965-2020·2020-09-23

    Randox Ammonia Reagent Recall Due to Positive Bias in Patient Samples

    Randox Laboratories is recalling 143 kits of AM1015 Ammonia reagents due to a positive bias of up to 140 µmol/L observed in patient samples.

    Product
    AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1582-2020·2020-09-23

    LUX EOI Hand Sanitizing Gel Recalled for Methanol Contamination

    Real Clean Distribuciones SA de CV is recalling LUX EOI Hand Sanitizing Gel because it contained methanol and was below the label claim for ethanol content.

    Product
    LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, Distributed by: Procurement Services, LLC Nashville, TN 37215, Product of Mexico. NDC 74882-007-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V568000·2020-09-21

    Nova Bus Recalls LFS Models Due to Power Steering Pipe Separation Risk

    Nova Bus is recalling 2019-2021 LFS and LFS ARTIC transit buses because power steering pipes may separate, causing fluid leaks and loss of steering assist.

    Product
    NOVA BUS — NOVA BUS LFS, LFS ARTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V566000·2020-09-18

    Newmar Recalls 2018-2021 Motorhomes Due to Tire Valve Stem Defect

    Newmar is recalling 2018-2019 Ventana and 2021 Canyon Star motorhomes because a tire valve stem extension may damage the inner wheel, risking loss of tire pressure and a crash.

    Product
    NEWMAR — NEWMAR CANYON STAR, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V565000·2020-09-18

    Braxton Creek Bushwhacker Travel Trailer Recall for Floor Separation Risk

    Braxton Creek is recalling 2020-2021 Bushwhacker travel trailers because undersized lag bolts may allow the floor to separate from the frame, increasing crash risk.

    Product
    BRAXTON CREEK — BRAXTON CREEK BUSHWACKER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2909-2020·2020-09-16

    CareFusion Alaris System PC Unit Model 8015 Recalled for Keypad Defect

    CareFusion is recalling Alaris System PC Unit Model 8015 infusion pumps because fluid ingress can cause unresponsive or stuck keypad keys, potentially delaying or interrupting medication infusions.

    Product
    Alaris System PC Unit Model 8015
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-2910-2020·2020-09-16

    CareFusion PC Unit Front Case with Keypad Replacement Kits Recalled

    CareFusion 303, Inc. is recalling PC Unit Front Case with Keypad Replacement Kits because fluid ingress may cause keys to become unresponsive or stuck, potentially delaying or interrupting life-sustaining infusions.

    Product
    PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, TC10013702 ASSY, CASE, FRONT W/KEYPAD, 8015LS, TC10013664 ASSY FR CASE W/ KEYPAD 8015 M2
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Drugs)·D-1564-2020·2020-09-16

    Just Hand Sanitizer Recalled for Methanol Labeling Error

    Open Book Extracts is recalling Just Hand Sanitizer because it was labeled to contain methanol.

    Product
    Just Hand Sanitizer (Ethyl Alcohol 73%) Single Use-Packs 100-count NDC 78065-2020-2 UPC 703123998598 (Single packs NDC 78065-2020-1 UPC 703123998659) Distributed by: Just Hand Sanitizer
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1565-2020·2020-09-16

    Shine & Clean Hand Sanitizer Recalled for Methanol and Low Ethanol

    Maquiladora Miniara S.A. de C.V. is recalling Shine & Clean Hand Sanitizer gel because FDA testing found undeclared methanol and ethanol levels below the label claim.

    Product
    Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carrerera Teoloyucan Huehuetoca km: 22 S/N La Planada Mexico C.P.: 54665 NDC 76753-001-01
    Category
    Drug
    Distribution
    Distributed nationwide