The Recall Desk

Severity 5 of 5

Critical recalls

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

What “critical” means here

Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.

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.

4051–4075 of 7439

  • CriticalFDA (Drugs)·D-0904-2016·2016-06-01

    Tiger King capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling Tiger King capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Tiger King, packaged in BIG BOX (10 small bottles / 10 capsules per bottle / 100 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0879-2016·2016-06-01

    Pink Bikini Strong Formula capsules recalled for undeclared ingredients

    Lucy's Weight Loss System is recalling Pink Bikini Strong Formula capsules because they contain undeclared sibutramine and phenolphthalein and were marketed without an approved NDA/ANDA.

    Product
    Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0895-2016·2016-06-01

    FDA Recalls Black Ant King for Lack of Approved New Drug Application

    R Thomas Marketing, LLC is recalling Black Ant King capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Black Ant King, packaged in BIG BOX (10 capsules / can / 12 cans per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1382-2016·2016-06-01

    Sausage Maker Seasoning Recalled for Undeclared Milk Allergens

    The Sausage Maker, Inc. is recalling Trail Bologna seasoning because it contains undeclared whey protein and skim milk powder.

    Product
    THE SAUSAGE MAKER SEASONING Trail Bologna under the following labels: 1) Net Wt 2 lbs. 8 oz, 2) Net Wt 25 lbs, 3) Trail Bologna Kit
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0873-2016·2016-06-01

    Sanofi Recalls Auvi-Q Epinephrine Auto-Injectors Due to Defective Delivery System

    Sanofi-Aventis is recalling 159,000 Auvi-Q epinephrine auto-injectors nationwide because a defective delivery system may result in inaccurate dosage delivery.

    Product
    Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0880-2016·2016-06-01

    FDA Recalls Weight Loss Capsules Containing Undeclared Sibutramine and Phenolphthalein

    Lucy's Weight Loss is recalling Shorts on The Beach Strong Formula capsules nationwide because they contain undeclared sibutramine and phenolphthalein.

    Product
    Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0877-2016·2016-06-01

    Smart Lipo Dietary Supplement Recalled for Undeclared Dangerous Ingredients

    Centro Naturista is recalling Smart Lipo Dietary Supplement capsules because they contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

    Product
    Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0870-2016·2016-06-01

    Avastin Syringes Recalled for Bacterial Contamination

    AmEx Pharmacy is recalling 836 Avastin syringes nationwide because testing revealed bacterial contamination.

    Product
    Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalNHTSA·16V384000·2016-05-31

    Ford Recalls Vehicles Due to Air Bag Inflator Rupture Risk

    Ford is recalling specific 2005-2011 vehicles because passenger air bag inflators may rupture in a crash, potentially causing serious injury or death.

    Product
    FORD — FORD, MERCURY, LINCOLN FORD GT, FUSION, MUSTANG, MILAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1614-2016·2016-05-25

    Monteris Medical Recalls NeuroBlate Laser Probes Due to Lens Fracture

    Monteris Medical Corp is recalling 121 NeuroBlate System SideFire Select 2.2 mm Directional Laser Probes because a sapphire lens fractured during a procedure, introducing CO2 into a patient's brain.

    Product
    NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01. NeuroBlate System SideFire Select Directional Laser Probes are part of the NeuroBlate System. The Monteris Me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1332-2016·2016-05-25

    Germinados Campo Verde Recalls Alfalfa Sprouts Linked to Salmonella

    Germinados Campo Verde is recalling alfalfa sprouts from Puerto Rico due to a link to seed contaminated with Salmonella.

    Product
    Alfalfa Sprout Product***Germinados Campo Verde***San Sebastian, Puerto Rico
    Category
    Food
    Distribution
    1 state
  • CriticalNHTSA·16V352000·2016-05-24

    Chrysler Recalls Vehicles Due to Passenger Air Bag Inflator Rupture Risk

    Chrysler is recalling approximately 4.6 million vehicles because passenger air bag inflators may rupture, sending metal fragments into the cabin. Owners are advised not to drive until repairs are complete.

    Product
    DODGE — DODGE, CHRYSLER, MITSUBISHI DAKOTA, CHARGER, DURANGO, CHALLENGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1330-2016·2016-05-18

    Garden of Life Raw Meal Organic Vanilla Spiced Chai Powder Recalled for Salmonella

    Garden of Life is recalling Raw Meal Organic Vanilla Spiced Chai Powder due to possible Salmonella contamination. The product was distributed nationwide and in several international markets.

    Product
    Raw Meal Organic Vanilla Spiced Chai Powder; Organic Shake and Meal Replacement; 909 g, 455 g, and 10-ct tray (65 g each). Packaged in plastic bottle with colored label.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1328-2016·2016-05-18

    Garden of Life Organic Chocolate Powder Recalled for Salmonella Risk

    Garden of Life is recalling Raw Meal Organic Chocolate Powder products due to possible Salmonella contamination. The recall covers 422,923 units distributed nationwide and internationally.

    Product
    Raw Meal Organic Chocolate Powder; Organic Shake and Meal Replacement; 986 g, 493 g, and 10-ct tray (65 g each). Packaged in plastic bottle with colored label.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1329-2016·2016-05-18

    Garden of Life Raw Meal Organic Powder Recalled for Salmonella Risk

    Garden of Life is recalling Raw Meal Organic Original Powder products due to possible Salmonella contamination. The recall affects 422,923 units distributed nationwide and internationally.

    Product
    Raw Meal Organic Original Powder; Organic Shake and Meal Replacement; 908 g, 454 g, and 10-ct tray (65 g each). Packaged in plastic bottle with colored label.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1044-2016·2016-05-18

    Meijer Frozen Butternut Squash Ravioli Recalled for Undeclared Cashew and Almond

    Bertagni 1882 is recalling Meijer frozen Butternut Squash Ravioli because the product may contain undeclared cashew and almond.

    Product
    Meijer frozen Butternut Squash Ravioli, product is packaged in a paper box, net weight 12 oz., UPC 760236398479
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-1327-2016·2016-05-18

    Garden of Life Raw Meal Organic Vanilla Powder Recalled for Salmonella Risk

    Garden of Life is recalling Raw Meal Organic Vanilla Powder products due to possible Salmonella contamination. The recall covers multiple lot codes distributed nationwide and internationally.

    Product
    Raw Meal Organic Vanilla Powder; Organic Shake and Meal Replacement; 949 g, 475 g, and 10-ct tray (68 g each). Packaged in plastic bottle with colored label.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalNHTSA·16E044000·2016-05-16

    Takata Frontal Passenger Air Bag Inflator Recall for Specific States

    Takata is recalling specific frontal passenger air bag inflators used in vehicles registered in 22 states due to a risk of rupture.

    Product
    AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1292-2016·2016-05-11

    Wonderful Pistachios Recalled Due to Salmonellosis Outbreak Link

    Wonderful Pistachios & Almonds, LLC. is recalling specific lots of Trader Joe's pistachios due to a link with a current Salmonellosis outbreak.

    Product
    Dry Roasted & Salted Inshell Pistachios; Packaged for Trader Joe's. Packaged in 16 oz. bag. UPC 00079983
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1320-2016·2016-05-11

    Kroger Raw Macadamia Nuts Recalled Due to Salmonella Contamination

    The Kroger Company is recalling raw macadamia nuts after positive Salmonella test results. Consumers should check their pantries for the specific UPC and sell-by date.

    Product
    Kroger Raw #4 Macadamia Nuts. UPC 2 04192 51053 2 Dist. by the Kroger Company Cincinnati, Ohio 45202
    Category
    Food
    Distribution
    18 states
  • CriticalFDA (Devices)·Z-1535-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Conductivity Sensors Due to Leakage Risk

    B Braun Medical Inc is recalling 68 Dialog+ Hemodialysis Conductivity Sensors due to a potential leakage hazard. The units were distributed nationwide to various states and territories.

    Product
    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1318-2016·2016-05-11

    Back To Nature Classic Creme Cookies Recalled for Undeclared Milk

    Back To Nature Foods is recalling Classic Creme Cookies because they contain undeclared milk. The recall covers 154,044 cartons shipped to 16 states.

    Product
    Classic Creme Cookies, Net wt. 12 oz cartons, 6 cartons per case. Manufactured for Back To Nature Foods Co., LLC
    Category
    Food
    Distribution
    Distributed nationwide