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.

2001–2025 of 7439

  • CriticalFDA (Food)·F-1323-2019·2019-05-08

    Hercules Candy Company Recalls Cashew Brittle Bits for Undeclared Peanuts

    Hercules Candy Company is recalling 15 bags of Cashew Brittle Bits because they may contain undeclared peanuts. Consumers should stop eating the product.

    Product
    Cashew Brittle Bits in clear 4oz bag with a Best By date of 07/14/19 and barcode number of 00369
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Devices)·Z-1116-2019·2019-05-01

    Edwards Lifesciences Recalls Fogarty Dilation Atrioseptostomy Catheters

    Edwards Lifesciences is recalling Fogarty Dilation Atrioseptostomy Catheters due to reports of balloon fragmentation or detachment and difficulty deflating the balloon after deployment.

    Product
    Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an ac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1406-2019·2019-05-01

    French cheese recalled due to potential Listeria monocytogenes contamination

    Societe Fromagere de la Brie is recalling French cheese products due to potential Listeria monocytogenes contamination. Consumers should not consume the affected items.

    Product
    Formagere de la Brie FORMAGE FRANCAIS l'Explorateur, packaged in a plastic container, in 100g, 250g - UPC: 3 390010004080, and 1kg packages.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1325-2019·2019-05-01

    Winter Gardens Chips & Chocolate Dessert Recalled for Salmonella Risk

    Winter Gardens Quality Foods is recalling Chips & Chocolate dessert trays due to potential Salmonella contamination. The product was distributed in Maryland, Pennsylvania, and Delaware.

    Product
    Chips & Chocolate, A layered dessert with chocolate mousse layer on the bottom, with a white whipped topping layer on top topped with chocolate chips, 5 lb. tray, UPC Code 010742015408
    Category
    Food
    Distribution
    3 states
  • CriticalCPSC·19112·2019-04-26

    Kids II Recalls All Rocking Sleepers Due to Infant Death Reports

    Kids II is recalling all Rocking Sleepers because five infant deaths have occurred. Consumers should stop using the product and contact the company for a refund.

    Product
    All models of Kids II Rocking Sleepers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1288-2019·2019-04-24

    NadaMoo! Strawberry Cheesecake Frozen Dessert Recalled for Undeclared Almonds

    Little Red Rooster Company is recalling NadaMoo! Strawberry Cheesecake Non-Dairy Frozen-Dessert because it contains undeclared almonds.

    Product
    NadaMoo! Strawberry Cheesecake Non-Dairy Frozen-Dessert 16 ounce/pint packaged in a carton
    Category
    Food
    Distribution
    25 states
  • CriticalFDA (Drugs)·D-1206-2019·2019-04-24

    Herbal Coffee Recalled for Undeclared Erectile Dysfunction Drugs

    The FDA is recalling Kopi Jantan Tradisional Natural Herbs Coffee because it contains undeclared sildenafil and tadalafil, unapproved drugs for erectile dysfunction.

    Product
    Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1135-2019·2019-04-17

    FDA Recalls Leopard Miracle Honey Containing Undeclared Sildenafil

    USA LESS Inc. is recalling Leopard Miracle Honey because it contains undeclared sildenafil, an unapproved drug for erectile dysfunction.

    Product
    LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sachet 15 gr / 0.53 Oz is labeled as LEOPARD Miracle of Honey, UPC 8 699415 912859, Manufactured in Turkey, www leopardhoneytr.com.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalCPSC·19105·2019-04-12

    Fisher-Price Recalls Rock 'n Play Sleepers Due to Infant Death Reports

    Fisher-Price is recalling all Rock 'n Play Sleepers because over 30 infant fatalities have occurred. Consumers should stop using the product immediately and contact the company for a refund.

    Product
    All Models of Rock 'n Play Sleeper
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1073-2019·2019-04-10

    Pfizer Recalls Sodium Bicarbonate Injection Vials Due to Glass Particulates

    Pfizer is recalling 8.4% Sodium Bicarbonate Injection vials because they contain glass particulates. The recall covers 283,400 vials distributed in the United States and Puerto Rico.

    Product
    8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Food)·F-1211-2019·2019-04-10

    FDA Recalls Chilean Salmon for Listeria monocytogenes Contamination

    Procesadora Aguas Claras LTDA. is recalling Premium Sustainable Atlantic Salmon from Chile due to a positive test for Listeria monocytogenes. The product was distributed to institutional customers in seven states.

    Product
    Premium Sustainable Atlantic Salmon (Farm Raised); 22 lb. case - Master carton - corrugated cardboard box. Internal Packaging: IQF vacuum packed with tray. Origin: Chili Packed for Osamu Corporation, Carson, CA For institutional use only
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1233-2019·2019-04-10

    Allen's Wild Blueberries Recalled for E. coli O157:H7 Contamination

    Allen's Blueberry Freezer, Inc. is recalling 37,800 pounds of Wild Sweet Allen's Wild Blueberries because the product tested positive for E. coli O157:H7.

    Product
    Wild Sweet ALLEN'S BLUEBERRIES WILD BLUEBERRIES IQF 30 LBS. NET 13.6 Kg. Packaged in a corrugated carton. Keep frozen at zero degrees F or below.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0977-2019·2019-04-10

    O-Two Medical e600 Ventilator Recalled for Fire Risk

    O-Two Medical is recalling 119 e600 Automatic Transport Ventilators because a manufacturing defect may cause the unit to catch fire.

    Product
    e600 Automatic Transport Ventilator, Model Number 01EVE600
    Category
    Medical Device
    Distribution
    8 states
  • CriticalFDA (Drugs)·D-1085-2019·2019-04-03

    Blue Fusion Capsules Recalled for Undeclared Prescription Ingredients

    Ata International Inc is recalling Blue Fusion Capsules because FDA analysis found undeclared prescription ingredients, including Sildenafil and Tadalafil.

    Product
    Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·038-2019·2019-03-26

    Aurora Packing Recalls Beef Products Due to Possible E. coli O157:H7 Contamination

    Aurora Packing Company is recalling approximately 4,838 pounds of beef heel and chuck tender products that may be contaminated with E. coli O157:H7.

    Product
    Aurora Packing Company, Inc. — Aurora Packing Company, Inc. Recalls Beef Products due to Possible E. coli O157:H7 Contamination
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Drugs)·D-0872-2019·2019-03-20

    FDA Recalls Dr. King's SafeCare Rx Muscle Maximizer Due to Microbial Contamination

    King Bio Inc. is recalling 94 bottles of Dr. King's SafeCare Rx Muscle Maximizer due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

    Product
    Dr. King's SafeCare Rx Muscle Maximizer, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955013327, NDC 57955-0133-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0661-2019·2019-03-20

    King Bio Children's Appetite Enhancer Recalled for Microbial Contamination

    King Bio Inc. is recalling Dr. King's Natural Medicine Children's Appetite Enhancer due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

    Product
    Dr. King's Natural Medicine Children's Appetite Enhancer for kids! Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955531821, NDC 57955-5318-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0750-2019·2019-03-20

    King Bio Recalls Dr. King's SafeCare Rx Sexual Identity Mind & Body

    King Bio Inc. is recalling Dr. King's SafeCare Rx Sexual Identity Mind & Body due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

    Product
    Dr. King's SafeCare Rx Sexual Identity Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955127024, NDC 57955-1271-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0764-2019·2019-03-20

    King Bio Recalls Aller-Detox Water Chemicals Due to Microbial Contamination

    King Bio Inc. is recalling 17 bottles of Dr. King's SafeCare Rx Aller-Detox: Water Chemicals U.S. due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

    Product
    Dr. King's SafeCare Rx Aller-Detox: Water Chemicals U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955340027, NDC 57955-3400-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0718-2019·2019-03-20

    King Bio Recalls Metabolic Mineral Modulator Due to Microbial Contamination

    King Bio Inc. is recalling Dr. King's SafeCare Rx M3 Metabolic Mineral Modulator due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

    Product
    Dr. King's SafeCare Rx M3 Metabolic Mineral Modulator, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955027621, NDC 57955-0277-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0982-2019·2019-03-20

    FDA Recalls King Bio Leg Cramp Relief Due to Microbial Contamination

    King Bio Inc. is recalling Dr. King's Natural Medicine Leg Cramp & Spasm Relief Homeopathic due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

    Product
    Dr. King's Natural Medicine Leg Cramp & Spasm Relief Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955543527, NDC 57955-6035-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0792-2019·2019-03-20

    King Bio Recalls Artery/Cholesterol/BP Product Due to Microbial Contamination

    King Bio Inc. is recalling Dr. King's SafeCare Rx Artery/Cholesterol/BP due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

    Product
    Dr. King's SafeCare Rx Artery/Cholesterol/BP, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955006428, NDC 57955-0064-2
    Category
    Drug
    Distribution
    Distributed nationwide