The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

11676–11700 of 29163

  • SevereNHTSA·19V563000·2019-07-31

    BMW Recalls 2018-2019 X3 and X4 Models for Seatback Welding Defect

    BMW is recalling 2018-2019 X3 and 2019 X4 vehicles because improperly welded front seatback frames may fold unexpectedly, increasing injury risk in a crash.

    Product
    BMW — BMW X3, X4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1524-2019·2019-07-31

    Geritrex Recalls Iron Elixir Due to Potential Microbial Contamination

    Geritrex, LLC is recalling Preferred Plus Pharmacy Iron Elixir due to cGMP deviations that may result in microbial contamination.

    Product
    Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 52807-177-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1521-2019·2019-07-31

    Geritrex Recalls Ritussin DM Due to Potential Microbial Contamination

    Geritrex, LLC is recalling 5,107 bottles of Ritussin DM Children & Adults due to cGMP deviations that may result in microbial contamination.

    Product
    Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-409-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1527-2019·2019-07-31

    Geritrex Recalls Preferred Plus Dioctyl Liquid Stool Softener Due to Microbial Contamination

    Geritrex, LLC is recalling Preferred Plus Dioctyl Liquid Stool Softener due to cGMP deviations that may result in microbial contamination.

    Product
    Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ Pharmaceutical Corp. 40 Commercial Avenue Middletown, NY 10941, Distributed by Kinray Inc. Whitestone, NY 11357, NDC 53807-216-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1498-2019·2019-07-31

    Pharma-Natural Recalls Double Tussin DM Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling 500 bottles of Double Tussin DM because the product was manufactured with current good manufacturing practice violations.

    Product
    DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2058-2019·2019-07-31

    Zyno Medical Administration Sets Recalled Due to Inverted Pinch Clamp Defect

    Zyno Medical LLC is recalling administration sets with inverted pinch clamps that may cause blood to be drawn from patients instead of delivering fluid.

    Product
    Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1526-2019·2019-07-31

    Gericare Geri-Tussin DM Recalled for Potential Microbial Contamination

    Geritrex, LLC is recalling Gericare Geri-Tussin DM due to cGMP deviations that may result in microbial contamination.

    Product
    Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street Brooklyn, NY, NDC 57896-660-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2081-2019·2019-07-31

    GammaPod Stereotactic Radiotherapy System Recalled for Alignment Drift

    Xcision Medical Systems is recalling two GammaPod Stereotactic Radiotherapy Systems because a loose bolt caused alignment drift and reduced radiation dose output.

    Product
    GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving…
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1520-2019·2019-07-31

    Geritrex Recalls Diphenhydramine Oral Liquid Due to Potential Microbial Contamination

    Geritrex, LLC is recalling 8,645 bottles of Diphenhydramine Oral Liquid due to cGMP deviations that may result in microbial contamination.

    Product
    Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-204-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1965-2019·2019-07-31

    Probar Meal Superfood Slam Bars Recalled for Undeclared Milk and Soy

    Probar LLC is recalling 2,908 Superfood Slam meal bars nationwide and in Canada due to undeclared milk and soy allergens.

    Product
    PROBAR MEAL Superfood Slam, Net Wt. 3oz.(85g), Film wrapped bar
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1582-2019·2019-07-31

    Brand Castle Recalls Grinch Sugar Cookie Mix Due to E. coli Risk

    Brand Castle LLC is recalling The Grinch Sugar Cookie Mix with Sprinkles because a supplier reported potential E. coli contamination in the flour used.

    Product
    The Grinch Sugar Cookie Mix with Sprinkles, 22.3 oz glass jar, 6/case
    Category
    Food
    Distribution
    10 states
  • SevereUSDA FSIS·080-2019·2019-07-27

    Premium Foods USA Recalls Siluriformes Fish Products Lacking Import Inspection

    Premium Foods USA is recalling 121,151 pounds of Siluriformes fish products imported from ineligible countries without required inspection.

    Product
    Premium Foods USA, Inc., Recalls Siluriformes Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    9 states
  • SevereNHTSA·19V557000·2019-07-26

    Temsa Recalls 2014-2019 TS45 Buses for Steering Hose Defect

    Temsa is recalling 2014-2019 TS45 buses because hydraulic steering hoses may leak or burst, potentially affecting steering ability and increasing crash risk.

    Product
    TEMSA — TEMSA TS45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·079-2019·2019-07-26

    Kent Quality Foods Recalls Sausage Due to Foreign Matter

    Kent Quality Foods is recalling ready-to-eat Polish sausage products due to possible contamination with flexible pink rubber pieces.

    Product
    Kent Quality Foods Inc. — Kent Quality Foods, Inc. Recalls Ready-To-Eat Sausage Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·19V561000·2019-07-26

    Moto Guzzi and Aprilia Motorcycles Recalled for Front Brake Master Cylinder Defect

    Piaggio is recalling specific Moto Guzzi and Aprilia motorcycles because a front brake master cylinder defect may cause unexpected slowing or stopping without warning to following traffic.

    Product
    MOTO GUZZI — MOTO GUZZI, APRILIA CALIFORNIA, DORSODURO, ELDORADO, AUDACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·078-2019·2019-07-25

    Home Market Foods Recalls Frozen Meatballs for Undeclared Allergens

    Home Market Foods is recalling approximately 53,217 pounds of frozen ready-to-eat beef and pork meatballs because they contain undeclared milk and wheat allergens.

    Product
    Home Market Foods, Inc. — Home Market Foods, Inc. Recalls Frozen Ready-To-Eat Beef and Pork Meatball Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-1486-2019·2019-07-24

    Pfizer Recalls Milrinone Lactate Injection Bags Due to Sterility Concerns

    Pfizer is recalling 58,200 bags of Milrinone Lactate Injection in 5% Dextrose due to a lack of assurance of sterility and potential for bag leaks.

    Product
    Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-1562-2019·2019-07-24

    ADM Recalls Bulk Flour Due to Potential E. coli O26 Presence

    ADM is recalling bulk flour products due to the potential presence of E. coli O26. The recall affects various flour brands distributed to retailers and commercial bakeries.

    Product
    Miss Minneapolis Product Code: 803003 Bulk flour
    Category
    Food
    Distribution
    Distributed nationwide