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.

9851–9875 of 29157

  • SevereFDA (Drugs)·D-1033-2020·2020-03-25

    Sun Pharmaceutical Recalls Doxycycline Capsules Due to Manufacturing Deviations

    Sun Pharmaceutical Industries is recalling 172,320 bottles of Doxycycline Capsules, 100 mg, because they were not manufactured under Current Good Manufacturing Practice conditions.

    Product
    DOXYCYCLINE — DOXYCYCLINE (DOXYCYCLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1474-2020·2020-03-25

    CME America BodyGuard Infusion Pump Systems Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard Infusion Pump Systems because they may deliver drugs at inaccurate rates, potentially causing faster or slower than expected medication administration.

    Product
    CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
    Category
    Medical Device
    Distribution
    45 states
  • SevereFDA (Drugs)·D-1031-2020·2020-03-25

    Mylan Recalls Sotalol HCL Tablets Due to Metal Particles

    Mylan Pharmaceuticals is recalling Sotalol HCL 80 mg tablets because of the presence of metal particles. The affected lot was distributed nationwide.

    Product
    Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1015-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling specific lots of Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1020-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling specific lots of Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V181000·2020-03-25

    2019 Freightliner and Mercedes-Benz Sprinter Brake Hose Recall

    Daimler Vans USA is recalling 2019 Freightliner and Mercedes-Benz Sprinter vans because a fender liner may chafe the brake hose, risking brake fluid loss and increased stopping distance.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 2500, SPRINTER 1500, SPRINTER 4500, SPRINTER (VS30)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1027-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0845-2020·2020-03-25

    Moonstruck Chocolate Recalls Praline Pecan Bars for Undeclared Milk

    Moonstruck Chocolate Company is recalling Praline Pecan & Ginger Element Bars due to undeclared milk, a major allergen.

    Product
    Moonstruck Praline Pecan & Ginger Element Bar in Dark Chocolate, packaged first into a clear poly film that is sealed. The sealed bar is then packed into a cardboard box (1 bar per box) that has label information. Net wt. 3.1 oz. The product SKU number is 312806 and the UPC code
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V176000·2020-03-23

    Freightliner Trucks Recalled for Axle Lubrication Defect

    Daimler Trucks is recalling 2019-2020 Freightliner M2 and 108SD trucks because insufficient axle lubrication may damage wheel bearings, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER BUSINESS CLASS M2, 108SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V175000·2020-03-23

    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 — FORD E-450, E-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V171000·2020-03-20

    Newmar Recalls Motorhomes Due to Insufficiently Tightened Brake Caliper Bolts

    Newmar is recalling specific 2019-2020 motorhomes because brake caliper mounting bolts may be loose, which can reduce braking effectiveness and increase crash risk.

    Product
    NEWMAR — NEWMAR LONDON AIRE, ESSEX, VENTANA, VENTANA LE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V168000·2020-03-20

    Terex Recalls 2009-2016 Aerial Devices Due to Lift Cylinder Defect

    Terex is recalling 2009-2016 TCX and SML aerial devices because lift cylinder rod eyes may fail, causing the boom to drift down and increasing injury risk.

    Product
    TEREX — TEREX TCX, SML
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V164000·2020-03-19

    BMW Recalls 2020 Models for Front Seat Belt Sensor Defect

    BMW is recalling 2020 models because front seat belt sensors may misread occupants, causing improper airbag and pretensioner deployment.

    Product
    BMW — BMW M850I, M340I, X3, X4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V158000·2020-03-19

    Forest River Recalls Vans Due to Transmission Shifter Cable Separation

    Forest River is recalling 2016-2020 vans because the transmission shifter cable may disconnect, causing unintended vehicle movement and crash risk.

    Product
    LONE STAR HANDICAP VANS — LONE STAR HANDICAP VANS, FOREST RIVER, COACHMEN L1 VAN, REV, ORION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V159000·2020-03-19

    Tremcar Recalls 2018-2020 Semi-Trailers Due to Brake Washer Fracture Risk

    Tremcar is recalling 2018-2020 406 and 407 semi-trailers because brake actuator washers may fracture, potentially reducing braking ability and increasing crash risk.

    Product
    TREMCAR — TREMCAR 406 SEMI-TRAILER, 407 SEMI-TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V165000·2020-03-19

    BMW Recalls 2020 R 1250 RT and GS Motorcycles for Driveline Defect

    BMW is recalling 2020 R 1250 RT and GS motorcycles because a damaged pivot pin may loosen the final drive connection, increasing crash risk.

    Product
    BMW — BMW R 1250 RT, R 1250 GS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V170000·2020-03-19

    Husqvarna 701 Motorcycles Recalled for Fuel Leak Fire Risk

    KTM is recalling 2018-2020 Husqvarna Vitpilen and Svartpilen 701 motorcycles because fuel may leak from the pump area, increasing fire risk.

    Product
    HUSQVARNA — HUSQVARNA VITPILEN 701, SVARTPILEN 701
    Category
    Vehicle
    Distribution
    Distributed nationwide