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.

1101–1125 of 7439

  • CriticalFDA (Drugs)·D-1540-2022·2022-09-21

    Propofol Injectable Emulsion Recalled for Particulate Matter Contamination

    Pfizer is recalling 5,390 vials of Propofol Injectable Emulsion due to the presence of particulate matter. The affected lot (EA7470, expiration 6/1/2023) was distributed nationwide.

    Product
    PROPOFOL — PROPOFOL (PROPOFOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1500-2022·2022-09-21

    CVS Health Magnesium Citrate Saline Laxative recalled for microbial contamination

    CVS Health Magnesium Citrate Saline Laxative is being recalled due to potential microbial contamination of the non-sterile product. Approximately 241,086 bottles were distributed nationwide.

    Product
    CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), a) UPC 0 50428 30594 2; b) UPC 0 50428 33517 8; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalCPSC·22221·2022-09-14

    ThyssenKrupp Residential Elevators Recalled Due to Child Entrapment Hazard

    ThyssenKrupp Access Corp. is recalling about 16,800 residential elevators sold between 1996 and 2012 due to an entrapment hazard. Children can become trapped in the gap between exterior and interior doors, resulting in serious injury or death; one child death has been reported.

    Product
    thyssenkrupp Access Corp. Residential Elevators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1690-2022·2022-09-14

    Select Bakery Cheese Streusel Supreme Recalled for Undeclared Walnuts and Food Colorants

    Select Bakery Cheese Streusel Supreme is recalled due to undeclared walnuts and food colorants. Consumers with allergies or sensitivities to walnuts, Yellow #5, Yellow #6, or Red #40 should not consume this product.

    Product
    Select Bakery Cheese Streusel Supreme Net Wt. 3 Oz (85g) Select Bakery, Inc., Rockwell, N.C. 28138 UPC 0 28598 10054 4
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Drugs)·D-1476-2022·2022-09-14

    Milk of Magnesia Recalled Nationwide for Microbial Contamination

    Plastikon Healthcare LLC has recalled Milk of Magnesia USP nationwide due to microbial contamination in non-sterile products. The affected lot (20071A) included approximately 24,400 institutional-use cups.

    Product
    MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1621-2022·2022-09-07

    Plant Protein Drink Recalled for Bacterial Contamination

    Lyons Magnus is recalling pirq Plant Protein Super Foods Very Strawberry Drink nationwide due to findings of Cronobacter sakazakii and Clostridium botulinum. Approximately 53.8 million units are affected in this Class I recall.

    Product
    pirq Plant Protein Super Foods, Very Strawberry Drink, Almonds, Curcumin, Maca. 11 FL OZ (325ML). UPC 8 57690-00830 0. Packaged in the following configurations: 1. 12 count case UPC 857690008331. 2. 4 count wrap UPC 857690008317. Chill it, Shake it. Do not Fr
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1585-2022·2022-09-07

    IQF Frozen Dill Recalled for Listeria Monocytogenes Contamination

    Supherb Farms is recalling IQF Fresh Frozen Dill nationwide and in Canada after testing detected Listeria Monocytogenes in the product. The recall affects approximately 25,009 pounds distributed in 35-pound bulk cases.

    Product
    IQF Fresh Frozen Dill shipped in 35 lb. cases in bulk. Supherb Farms Turlock, CA Perishable, Keep Frozen
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1611-2022·2022-09-07

    Lyons Ready Care 2.0 Chocolate Drink Recalled for Potential Bacterial Contamination

    Lyons Magnus recalls Lyons Ready Care 2.0 Chocolate Nutritional Drink nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected units have lot codes 8212 and 9302.

    Product
    Lyons Ready Care 2.0 Chocolate High Calorie, High Protein, Nutritional Drink. 32 FL OZ (1 QT) 946mL UPC 0 45796-10050 3 Item 10050. 12 count case UPC 10045796100500. Refrigerate after opening. Lyons Magnus, Fresno, CA 93702.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1668-2022·2022-09-07

    Kate Farms Nutrition Shake recalled for bacterial contamination nationwide

    Lyons Magnus is recalling Kate Farms Nutrition Shake, Chocolate nationwide due to findings and potential for Cronobacter sakazakii and Clostridium botulinum contamination.

    Product
    kate farms Nutrition Shake, Chocolate. 11 fl oz (325 mL) UPC 8 11112-03060 7. 12 count case UPC 00811112030614. Shake Well. After opening, refrigerate and use within 4 days. Made for Kate Farms, Inc., 101 Innovation Place, Santa Barbara, CA 93708
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1636-2022·2022-09-07

    Lactation Smoothie Recalled Nationwide Due to Bacterial Contamination

    Sweetie Pie Organics Lactation Smoothie is recalled nationwide due to contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume affected products.

    Product
    Sweetie Pie Organics Lactation Smoothie Apple Pear. 11.1 FL OZ (330 mL) UPC 8 56334-00254 4. No. 975001. Packaged in the following configurations: 1. 12 count case 2. 4 count wrap UPC 856334002575. Refrigerate after opening and consume within 24 hours. Distri
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1635-2022·2022-09-07

    Lactation Smoothie Recalled Nationwide for Potential Bacterial Contamination

    Sweetie Pie Organics Lactation Smoothie Mango Banana is recalled due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The recall affects 53,818,025 units distributed nationwide.

    Product
    Sweetie Pie Organics Lactation Smoothie Mango Banana. 32 FL OZ (1 QT) 946mL UPC 8 56334-00278 0. No. 955001. Packaged in the following configurations: 1. 12 count case 2. 4 count wrap UPC 856334002810. Refrigerate after opening and consume within 24 hours. Distr
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1634-2022·2022-09-07

    Nutritional Drink Recalled for Potential Cronobacter and Botulinum Contamination

    Sysco Imperial Med Plus 2.0 nutritional drink is recalled nationwide for potential contamination with Cronobacter sakazakii and Clostridium botulinum. The FDA classified this as Class I.

    Product
    Sysco Imperial Med Plus 2.0 butter Pecan Nutritional Drink. High Calorie, High Protein. Mildly Thick Nectar Consistency. 32 FL OZ (1 QT) 946mL UPC 0 74865-92732 1. Reorder # 0108936. 12 count case UPC 10074865927328. Refrigerate prior to serving. Shake well. Ref
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1644-2022·2022-09-07

    Stumptown Cold Brew Coffee Recalled for Cronobacter and Botulism Risk

    Stumptown Cold Brew Coffee with Oatmilk Original is recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. This FDA Class I recall affects approximately 53.8 million units.

    Product
    Stumptown Cold Brew Coffee with Oatmilk Original. Made with Oatly! Low Sugar. 11 Fl Oz. 325 ML. UPC 8 55186-00687 8. Sold in 12-count case UPC 108551860006844. Manufactured for Stumptown Coffee Roasters, 100 SE Salmon St. Portland, OR 97214
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1624-2022·2022-09-07

    Premier Protein Vanilla Shake recalled for bacterial contamination

    Premier Protein Vanilla High Protein Shake is recalled due to findings and potential for Cronobacter sakazakii and Clostridium botulinum in a nationwide distribution of 53,818,025 units.

    Product
    Premier Protein Vanilla High protein shake. 11 FL OZ (325mL). Packaged in the following configurations: 1. Carton UPC 6 43843-71535 1 packed in 18 count case UPC 643843718642. 2. Carton UPC 6 43843-71450 7 packed in 12 count case UPC 643843713944. 3. Carton UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1648-2022·2022-09-07

    Lyons Plant-Based Protein Shake Recalled for Bacterial Contamination

    Lyons Magnus is recalling Lyons Ready Care Plant-Based Protein Shake Chocolate nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum, serious bacterial pathogens that can cause illness.

    Product
    Lyons Ready Care Plant-Based Protein Shake Chocolate. 8.45 fl oz. (250mL) UPC 0 45796-10081 7. Mildly Thick Nectar Consistency. Refrigerate prior to serving. Shake Well. Sold in 24-count case UPC 10045796100814. Lyons Magnus, Fresno, CA 93702.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1522-2022·2022-08-31

    INTERA 3000 implantable pump recalled for higher-than-expected flow rate

    The FDA is recalling INTERA 3000 implantable hepatic infusion pumps due to a malfunction causing higher-than-expected medication flow rates. Patients should contact their healthcare provider.

    Product
    INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
    Category
    Medical Device
    Distribution
    13 states
  • CriticalFDA (Food)·F-1596-2022·2022-08-24

    Kingdom Creamery 8.5% Gelato Mix Products Recalled for Potential Listeria Contamination

    Kingdom Creamery of Vermont is recalling 8.5% Gelato Mix due to potential Listeria monocytogenes contamination. The recall involves 1,623 cases distributed in Vermont, Maine, and Massachusetts.

    Product
    SOCO 8.5% Gelato Mix; 8.5% Gelato Mix; both labels list Kingdom Creamery of Vermont
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Drugs)·D-1342-2022·2022-08-24

    Hand sanitizer recalled for methanol contamination and insufficient ethanol

    Medek LLC is recalling M Hand Sanitizer due to FDA analysis finding methanol contamination and ethanol levels below label claims. Approximately 256 bottles distributed in Texas.

    Product
    M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. Puebla 105 Col. Rodriguez Reynosa, Tam, Mexico C.P. 88630, NDC Code: 77797-001-01, Distributed by: Medek, LLC 315 E. Business Hwy 83 Alamo, TX
    Category
    Drug
    Distribution
    1 state
  • CriticalCPSC·22200·2022-08-15

    4moms MamaRoo and RockaRoo Baby Swings and Rockers Strangulation Hazard

    4moms is recalling over 2 million MamaRoo baby swings and 220,000 RockaRoo rockers because dangling restraint straps pose a strangulation hazard to crawling infants. One death has been reported.

    Product
    4moms MamaRoo Baby Swing, versions 1.0 through 4.0 and RockaRoo Baby Rockers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1513-2022·2022-08-10

    Pecan Deluxe Candy Double Fudge Blend recalled for undeclared peanut allergen

    Pecan Deluxe Candy Company is recalling Double Fudge Blend candy due to potential undeclared peanut content, which poses a risk to consumers with peanut allergies.

    Product
    Double Fudge Blend (04-3118-35) 35lbs. (15.88 KG) packaged in a blue plastic bag (ZZ500) inside a printed corrugated box (ZZ240),
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1292-2022·2022-08-03

    Insulin Glargine Prefilled Pens Recalled for Missing Label

    Mylan Pharmaceuticals is recalling Insulin Glargine prefilled pens (lot BF21002895) distributed nationwide because some pens lack labels, which could prevent patients from properly identifying and administering the medication.

    Product
    Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specia
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1188-2022·2022-07-20

    Morphine Sulfate Extended-Release Tablets Recalled for Strength Label Mix-up

    Bryant Ranch Prepack has recalled Morphine Sulfate extended-release tablets due to a label mix-up where bottles may contain the wrong strength. Contact your pharmacy to verify your correct dose.

    Product
    Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., NJ; Relabeled by: Bryant Ranch Prepack, Inc, CA, NDC 63629-1089-01
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Food)·F-1402-2022·2022-07-13

    Prairie City Bakery Peanut Butter Chocolate Chip Cakes Recalled for Salmonella

    Prairie City Bakery is recalling Peanut Butter Chocolate Chip Ooey Gooey Butter Cakes due to Salmonella contamination from recalled Jif peanut butter ingredient. Products were distributed to gas stations and convenience stores nationwide.

    Product
    Prairie City Bakery Peanut Butter Chocolate Chip Ooey Gooey Butter Cake 2oz. individual UPC: 7-9788436718-2; 10 individual units per display unit; 6 display units per wholesale case.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1399-2022·2022-07-13

    Giant Eagle Cupcakes Recalled Due to Salmonella Contamination Risk

    Giant Eagle Cupcakes (GE Cupcake 6 Buckeye, 18Oz) recalled due to potential Salmonella contamination from Jiff Peanut Butter. 14 units distributed to Pennsylvania.

    Product
    GE 29765500000 Cupcake 6 Buckeye 18Oz
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1319-2022·2022-07-13

    Palindrome HSI Chronic Catheter Recalled for Potential Hub Leaking

    Covidien is recalling Palindrome HSI Chronic Catheters due to a potential leaking condition in the catheter hub that may cause unanticipated fluid return during dialysis. Approximately 13,526 units distributed worldwide are affected.

    Product
    Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide