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.

3451–3475 of 7439

  • CriticalFDA (Drugs)·D-0218-2017·2016-12-28

    Hospira Recalls Bupivacaine Hydrochloride Vials Due to Particulate Matter

    Hospira Inc. is recalling 143,250 vials of Bupivacaine Hydrochloride Injection due to a confirmed report of particulate matter in a single vial.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0731-2017·2016-12-28

    Woodland Foods Recalls Smashburger Autumn Harvest Salad Topper Due to Listeria Risk

    Woodland Foods is recalling Smashburger Autumn Harvest Salad Topper because sunflower seeds used in the product may be contaminated with Listeria.

    Product
    Product is packaged into a plastic bag and placed into cardboard box. Product is labeled as "smashburger Autumn Harvest Salad Topper".
    Category
    Food
    Distribution
    25 states
  • CriticalFDA (Food)·F-0887-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe and Fruit Mixes for Listeria Risk

    Simply Fresh Fruit is recalling cantaloupe and fruit mixes containing cantaloupe due to potential Listeria monocytogenes contamination.

    Product
    4/1 GL CANT/HONEYDEW/PINEAPPLE 3/4", UPC 4294740192
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0884-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe and Fruit Mixes for Listeria Risk

    Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.

    Product
    **1) 1 GL PAIL SFF FRUIT MIX, UPC #3522300553 and UPC4294710155; **2) 3 GL PAIL SFF FRUIT MIX, UPC #4294710355; **3) 4GL PAIL SFF FRUIT MIX UPC #4294710455; **4) 2/1 GL Case SFF Fruit Mix UPC 4294720155; **5) 4/1 GL case SFF Fruit Mix UPC #4294740155. ... **3) 4 GL PAIL
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0728-2017·2016-12-28

    Woodland Foods Recalls D'Allesandro Almond Trail Mix Due to Listeria Risk

    Woodland Foods is recalling D'Allesandro Almond Trail Mix because sunflower seeds in the product may be contaminated with Listeria.

    Product
    Product is packaged into a plastic bag and placed into cardboard box. Product is labeled as "D'ALLESANDRO ALMOND TRAIL MIX". Product was packaged into 5 lb boxes.
    Category
    Food
    Distribution
    25 states
  • CriticalFDA (Food)·F-0891-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe Chunks Due to Listeria Risk

    Simply Fresh Fruit is recalling 50 pails of cantaloupe chunks because they may be contaminated with Listeria monocytogenes.

    Product
    1 GL PAIL SYSCO CANTALOUPE CHUNKS - LS, UPC 7486548718
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0888-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe Mixes Due to Listeria Risk

    Simply Fresh Fruit is recalling cantaloupe and fruit mixes in grape juice because they may be contaminated with Listeria monocytogenes.

    Product
    1 GL PAIL and 2x1 GL/case SFF FRUIT MIX IN GRAPE JUICE, UPC 4294717155
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0223-2017·2016-12-28

    Skinny Bee Diet capsules recalled for undeclared dangerous ingredients

    Love My Tru Body is recalling Skinny Bee Diet capsules because they contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

    Product
    Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0229-2017·2016-12-28

    Sage Products Recalls Comfort Shield Barrier Cream Cloths Due to Bacteria

    Sage Products LLC is recalling Comfort Shield Barrier Cream Cloths because they are contaminated with Burkholderia cepacia bacteria.

    Product
    COMFORT SHIELD BARRIER — COMFORT SHIELD BARRIER (DIMETHICONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0730-2017·2016-12-28

    Woodland Foods Recalls Sunflower Seeds for Listeria Contamination

    Woodland Foods is recalling Di Bruno Bros Roasted & Salted Sunflower Seeds due to potential Listeria contamination. The product was distributed to food distributors in 25 states.

    Product
    Product is packaged into a plastic bag and placed into cardboard box. Product is labeled as "DI BRUNO BROS ROASTED & SALTED SUNFLOWER E SEEDS".
    Category
    Food
    Distribution
    25 states
  • CriticalFDA (Drugs)·D-0210-2017·2016-12-28

    Ultimate Body Tox PRO capsules recalled for undeclared sibutramine

    FDA is recalling Ultimate Body Tox PRO capsules because they contain undeclared sibutramine, a controlled substance removed from the market for safety reasons.

    Product
    Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0216-2017·2016-12-28

    Honeywell Eyesaline Eyewash Recalled for Klebsiella Pneumoniae Contamination

    Sperian Eye & Face Protection is recalling 9,744 bottles of Honeywell Eyesaline Eyewash Sterile Isotonic Solution due to non-sterility and contamination with Klebsiella pneumoniae.

    Product
    Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0896-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe and Fruit Mixes for Listeria Risk

    Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.

    Product
    1 GL PAIL SYSCO IMP. CANTALOUPE/GRAPE JUICE, UPC 7486562450
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0221-2017·2016-12-28

    FDA Recalls Black Gold X Advanced Capsules for Undeclared Sibutramine

    The FDA is recalling Black Gold X Advanced capsules because they contain undeclared sibutramine and were marketed without an approved NDA/ANDA.

    Product
    BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0879-2017·2016-12-28

    Simply Fresh Fruit Recalls Tropical Salad Due to Listeria Risk

    Simply Fresh Fruit is recalling 1-gallon pails of Tropical Salad because they may be contaminated with Listeria monocytogenes.

    Product
    1 GAL PAIL SYSCO IMP. TROPICAL SALAD - LS, UPC 7486563429
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0883-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe Mixes Due to Listeria Risk

    Simply Fresh Fruit is recalling 4 GL pails of fruit mix with cantaloupe because they may be contaminated with Listeria monocytogenes.

    Product
    4 GL PAIL FRUIT MIX-SMALL CUT, UPC 4294710455
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0903-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe Mixes Due to Listeria Risk

    Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.

    Product
    2/1 GL SFF TROPICAL MIX IN GRAPE JUICE, UPC 4294727161
    Category
    Food
    Distribution
    Distributed nationwide