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.

4601–4625 of 4878

  • SevereFDA (Food)·F-0892-2021·2021-09-08

    BrightFarms Lakeside Crunch Salad Recalled for Potential Salmonella Contamination

    BrightFarms Lakeside Crunch salad, sold in 4oz packages, is being recalled due to potential Salmonella contamination. The product was distributed across Illinois, Wisconsin, Iowa, Indiana, and Michigan.

    Product
    BrightFarms Lakeside Crunch; packaged in clear, plastic clamshell; 4oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0778-2021·2021-09-08

    Hand Sanitizer Gel Recalled Due to Methanol Contamination Risk

    Global Sanitizers LLC is recalling MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel (70% ethyl alcohol) due to manufacturing deviations. Products were made under the same conditions as a lot found to contain methanol.

    Product
    MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0889-2021·2021-09-08

    BrightFarms Spring Mix Recalled Due to Salmonella Risk

    BrightFarms Spring Mix sold in 4oz and 8oz clamshells may be contaminated with Salmonella. The product was distributed across Illinois, Wisconsin, Iowa, Indiana, and Michigan with best-by dates through July 29, 2021.

    Product
    BrightFarms Spring Mix; packaged in clear, plastic clamshells; 4oz and 8oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0890-2021·2021-09-08

    BrightFarms Harvest Crunch Salmonella Contamination Recall

    BrightFarms Harvest Crunch packaged salad may be contaminated with Salmonella. The recall affects products distributed in Illinois, Wisconsin, Iowa, Indiana, and Michigan with best-by dates through July 29, 2021.

    Product
    BrightFarms Harvest Crunch; packaged in clear plastic clamshells; 4oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0779-2021·2021-09-08

    MEDICALLY MINDED Hand Sanitizer Gel Recalled for Methanol Contamination

    Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel (8.5 FL OZ) due to potential methanol contamination. The product was manufactured under the same conditions as a lot previously found to contain methanol.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ (250 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Ma
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0888-2021·2021-09-08

    BrightFarms Sunny Crunch Lettuce Recalled for Salmonella Risk

    Bright Farms is recalling BrightFarms Sunny Crunch lettuce sold in 4oz and 8oz plastic clamshells because the product may be contaminated with Salmonella.

    Product
    BrightFarms Sunny Crunch; packaged in clear, plastic clamshells; 4oz and 8oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0896-2021·2021-09-08

    BrightFarms Mighty Romaine Recalled for Potential Salmonella Contamination

    BrightFarms is recalling Mighty Romaine lettuce sold in 4oz and 8oz clamshells because the product may be contaminated with Salmonella.

    Product
    BrightFarms Mighty Romaine; packaged in clear, plastic clamshells; 4oz and 8oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0932-2021·2021-09-08

    Spicy Shrimp Tempura Roll recalled for Salmonella contamination

    Mai Cuisine's 12 PC Spicy Shrimp Tempura Roll is being recalled due to Salmonella contamination in frozen shrimp used in the product. The recall affects approximately 1,490 packages sold at Genji Sushi counters inside Whole Foods Market stores in Northern California.

    Product
    12 PC Spicy Shrimp Tempura Roll [WR] UPC: 81244803385 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0891-2021·2021-09-08

    BrightFarms 50/50 Spring & Spinach Salmonella Contamination Recall

    BrightFarms 50/50 Spring & Spinach in 4oz clamshells may be contaminated with Salmonella. The product was distributed in Illinois, Wisconsin, Iowa, Indiana, and Michigan with best-by dates through July 29, 2021.

    Product
    BrightFarms 50/50 Spring & Spinach; packaged in clear plastic clamshells, 4oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·21V523000·2021-09-07

    Recreational vehicles recalled for defective window adhesive on multiple models

    Forest River and Coachmen recreational vehicles with Hehr 6400 Series windows are being recalled due to adhesive failure that may cause window vents to detach. Detachment increases the risk of crashes and injuries.

    Product
    FOREST RIVER — 2013 FOREST RIVER BLUE RIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0881-2021·2021-09-01

    Cahills Ireland Original Irish Porter Cheese Recalled for Listeria

    Cahills Farm Cheese Limited is recalling Cahills Ireland Original Irish Porter cheese products due to possible Listeria monocytogenes contamination. The recall affects approximately 4.4 tons distributed nationwide.

    Product
    1. Cahills Ireland Original Irish Porter 5lbs.Waxed Deli Wheel 2. Cahills Ireland Original Irish Porter 2.4 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0882-2021·2021-09-01

    Cahills Ireland Red Wine Cheese Recalled for Listeria Risk

    Cahills Farm Cheese Limited is recalling Cahills Ireland Red Wine - 5 lbs. Waxed Deli Wheel cheese nationwide because it may be contaminated with Listeria monocytogenes, a serious foodborne pathogen.

    Product
    Cahills Ireland Red Wine - 5 lbs. Waxed Deli Wheel
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0767-2021·2021-09-01

    SterRx Sodium Bicarbonate Injection Recalled for Non-Sterility

    SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection due to microbial contamination confirmed by third-party laboratory testing. The affected product is a prescription intravenous injection distributed nationwide.

    Product
    Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0883-2021·2021-09-01

    Lidl Irish Stout Cheddar Cheese Recalled for Listeria Contamination

    Lidl Preferred Selection Irish Stout Cheddar cheese may be contaminated with Listeria monocytogenes. Affected products were distributed nationwide and should not be consumed.

    Product
    Lidl Preferred Selection-Irish Stout Cheddar - 7 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0773-2021·2021-09-01

    Trulicity autoinjector pens recalled for incorrect strength labeling

    Eli Lilly & Company is recalling Trulicity (dulaglutide) 0.75 mg autoinjector pens because some contain double the labeled strength. Affected patients may receive an incorrect dose.

    Product
    TRULICITY — TRULICITY (DULAGLUTIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2286-2021·2021-09-01

    Sodium Chloride Flush Syringe Recalled Due to Plunger Malfunction Risk

    Cardinal Health is recalling Monoject 0.9% Sodium Chloride Flush Syringes because the plunger may draw back after use and reintroduce air into the syringe.

    Product
    Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0765-2021·2021-09-01

    Fludarabine Phosphate Injection Recalled Due to Sterility Concern

    Custopharm, Inc. is recalling Fludarabine Phosphate for Injection, USP 50 mg because the manufacturer detected microbial contamination during environmental monitoring in aseptic manufacturing areas, raising sterility assurance concerns.

    Product
    FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0768-2021·2021-09-01

    SterRx Sodium Bicarbonate in 5% Dextrose Injection Recalled for Sterility Concerns

    SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection (1,000 mL bags) nationwide due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider immediately.

    Product
    Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2284-2021·2021-09-01

    Monoject flush syringe recall: plunger may reintroduce air into IV lines

    Cardinal Health Monoject flush syringes may have a defect allowing the plunger to draw back and reintroduce air into the syringe. The FDA issued a Class I recall for over 267 million units distributed nationwide.

    Product
    Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0880-2021·2021-09-01

    Cahills Ireland Whiskey Cheese recalled for Listeria monocytogenes contamination

    Cahills Farm Cheese Limited is recalling Cahills Ireland Whiskey Cheese 5lb. Waxed Deli Wheels due to potential Listeria monocytogenes contamination. The affected product was distributed nationwide.

    Product
    Cahills Ireland Whiskey Cheese - 5lb. Waxed Deli Wheel
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0772-2021·2021-09-01

    Atovaquone Oral Suspension Recalled for Temperature Abuse

    KVK-Tech, Inc. is recalling Atovaquone Oral Suspension due to temperature abuse that caused unusual grittiness in the product. The defect may affect the medication's quality and safety.

    Product
    ATOVAQUONE ORAL SUSPENSION — ATOVAQUONE ORAL SUSPENSION (ATOVAQUONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0885-2021·2021-09-01

    Wavy Lay's Original Potato Chips Recalled for Undeclared Milk

    Frito-Lay is recalling Wavy Lay's Original Potato Chips with specific manufacturing codes due to possible undeclared milk. Consumers with milk allergies should not consume the affected product.

    Product
    Wavy Lay s Original Potato Chips UPC 0 28400 04380 9 packaged in flexible bag
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0884-2021·2021-09-01

    Lidl Preferred Selection Red Wine Cheddar Recalled for Listeria

    Cahills Farm Cheese Limited is recalling Lidl Preferred Selection Red Wine Cheddar cheese due to potential Listeria monocytogenes contamination. Consumers should not eat this product.

    Product
    Lidl Preferred Selection-Red Wine Cheddar - 7 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0770-2021·2021-09-01

    Miss Slim capsules recalled for unapproved marketing distribution

    HIS ENTERPRISE INC is recalling all lots of Miss Slim capsules (10-count and 30-count boxes) distributed nationwide in the USA because the product was marketed without required FDA approval (ANDA/NDA).

    Product
    Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0911-2021·2021-08-25

    HiPP Dutch Stage 2 Infant Formula Missing Pre-Market Approval and Labeling

    Able Groupe Inc is recalling HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula because required pre-market notifications were not submitted to the FDA and products lack mandatory English labeling statements.

    Product
    HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula
    Category
    Food
    Distribution
    0 states