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.

4026–4050 of 7439

  • CriticalFDA (Food)·F-1428-2016·2016-06-15

    Rucker's Recalls Uncle Buck's Trail Mix Due to Listeria Risk

    Rucker's Wholesale & Service Co. is recalling Uncle Buck's Sweet & Salty trail mix because an ingredient may be contaminated with Listeria monocytogenes.

    Product
    labled in part "Uncle Buck's Sweet & Salty trail mix" packaged in a clear 3 oz plastic bag with attached green and orange label with yellow and black writing. item number: 7339, UPC # 752545073390.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0957-2016·2016-06-15

    Baxter Recalls Sodium Chloride Injection Due to Insect Particulate Matter

    Baxter Healthcare is recalling 255,852 bags of 0.9% Sodium Chloride Injection because customers reported finding an insect in the primary container.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0964-2016·2016-06-15

    Novacare Recalls MetaPro 360 Supplement Containing Unapproved Salicylic Acid

    Novacare, LLC is recalling MetaPro 360 Metabolic Accelerator dietary supplements because FDA sampling confirmed the presence of salicylic acid, an unapproved drug ingredient.

    Product
    MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in 120 capsule containers. www.metapro360.com 877-778-7509.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0966-2016·2016-06-15

    FDA Recalls Thin and Slim Thermogenic Fat Burner for Unapproved Ingredient

    Novacare, LLC is recalling The Store Thin and Slim Thermogenic Fat Burner because FDA sampling found salicylic acid, an ingredient not approved for dietary supplements.

    Product
    The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement packaged in 90 capsule containers. Distributed by The Store 2050 E. 6200 S., Holladay, UT 84121, The Store Holliday, 4695 S.Holladay Blvd, Holladay, UT 84117, The Store Midway, 42 W. Main Street, Midway, UT 84049.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1415-2016·2016-06-08

    Kroger Sunflower Kernels Recalled for Potential Listeria Contamination

    The Kroger Co is recalling Roasted & Salted Sunflower Kernels due to potential Listeria monocytogenes contamination.

    Product
    Kroger SALAD TOPPERS Roasted & Salted Sunflower Kernels NET WT 3.5 OZ (99G) INGREDIENTS: SUNFLOWER KERNELS, COTTONSEED AND/OR SUNFLOWER OILS, SALT DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 02127 4
    Category
    Food
    Distribution
    28 states
  • CriticalFDA (Food)·F-1413-2016·2016-06-08

    FDA Recalls Fresh Long Chili Peppers Due to Salmonella Contamination

    Patel Shippers Inc is recalling fresh long chili peppers imported from the Dominican Republic because they tested positive for Salmonella.

    Product
    Fresh Long Chili Peppers, Raw, 10 lb box. Imported from Dominican Republic.
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1414-2016·2016-06-08

    Kroger Cranberry Trail Mix Recalled for Potential Listeria Contamination

    The Kroger Co is recalling Cranberry Delight Trail Mix because it may be contaminated with Listeria monocytogenes.

    Product
    Kroger CRANBERRY DELIGHT TRAIL MIX NET WT 14 OZ INGREDIENTS: DRIED CRANBERRIES ***ALMONDS, SUNFLOWER SEEDS*** UPC 0 11110 89869 2 DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202
    Category
    Food
    Distribution
    28 states
  • CriticalFDA (Food)·F-1416-2016·2016-06-08

    Kroger Salted Sunflower Kernels Recalled for Listeria Contamination

    The Kroger Co is recalling Salted Sunflower Kernels because the supplier notified the firm that the product may be contaminated with Listeria monocytogenes.

    Product
    Kroger SALTED SUNFLOWER KERNELS 6 oz (170g) INGREDIENTS: SUNFLOWER KERNELS, COTTONSEED AND/OR SUNFLOWER OILS, SALT. DISTRIBUTED BY THE KROGER CO CINCINNATI, OHIO 45202 UPC 0 11110 61877 1
    Category
    Food
    Distribution
    28 states
  • CriticalFDA (Drugs)·D-0908-2016·2016-06-01

    Licorice Coughing Liquid Recalled for Undeclared Morphine

    Master Herbs is recalling Licorice Coughing Liquid because it contains undeclared morphine and was marketed without an approved NDA or ANDA.

    Product
    Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manufactured by: Ma Ying Long Pharmaceutical Group Co., LTD, Wuhan, China; Distributed by: Master Herbs (USA) Inc., NDC 68511-0460-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0888-2016·2016-06-01

    Weekend Prince capsules recalled for lack of FDA approval

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

    Product
    Weekend Prince, packaged in 24 individual cards / 2 capsules per card/ 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0905-2016·2016-06-01

    FDA Recalls Samurai-X Capsules Marketed Without Approval

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

    Product
    Samurai-X, packaged in BIG BOX (24 individually wrapped capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0881-2016·2016-06-01

    FDA Recalls Weight Loss Product Containing Undeclared Sibutramine and Phenolphthalein

    Lucy's Weight Loss System is recalling Shorts on The Beach Golden Edition because it contains undeclared sibutramine and phenolphthalein.

    Product
    Shorts on The Beach Golden Edition by Pink Bikini, 800 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-0878-2016·2016-06-01

    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, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0860-2016·2016-06-01

    Lipo Escultura capsules recalled for containing unapproved prescription drugs

    Lipo Escultura capsules are being recalled because they contain sibutramine and diclofenac, making them unapproved drugs rather than dietary supplements.

    Product
    LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0871-2016·2016-06-01

    Pharmakon Recalls Morphine Sulfate Syringes Due to High Potency

    Pharmakon Pharmaceuticals is recalling 75 syringes of Morphine Sulfate 0.5 mg/mL due to out-of-specification potency results indicating high levels.

    Product
    Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0894-2016·2016-06-01

    FDA Recalls Unapproved Male Enhancement Product Sold Nationwide Online

    The FDA is recalling 'Bigger Longer More Time More Sperms' because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 capsules per small box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0863-2016·2016-06-01

    Baxter Recalls Metronidazole Injection Bags Due to Cloth Fiber Particulate Matter

    Baxter Healthcare Corp. is recalling 334,560 bags of Metronidazole Injection USP due to the presence of a cloth fiber. The product was distributed nationwide and in Puerto Rico.

    Product
    METRONIDAZOLE — METRONIDAZOLE (METRONIDAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0887-2016·2016-06-01

    FDA Recalls Stree Overlord Capsules Marketed Without Approval

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

    Product
    Stree Overlord, packaged in 10 small boxes / 1 capsule per box, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0900-2016·2016-06-01

    Hard Ten Days capsules recalled for lack of FDA approval

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

    Product
    Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0897-2016·2016-06-01

    Germany Niubian Recalled for Lack of FDA Approval

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

    Product
    Germany Niubian, packaged in BIG BOX (10 small boxes / 24 capsules per box / 240 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0882-2016·2016-06-01

    Pink Bikini capsules recalled for undeclared dangerous ingredients

    Lucy's Weight Loss System is recalling Pink Bikini capsules because they contain undeclared Sibutramine, Phenolphthalein, and/or Diclofenac.

    Product
    Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0869-2016·2016-06-01

    Avastin Syringes Recalled for Bacterial Contamination

    AmEx Pharmacy is recalling 45 Avastin syringes nationwide because testing revealed bacterial contamination.

    Product
    Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0883-2016·2016-06-01

    Shorts on the Beach capsules recalled for undeclared dangerous ingredients

    Lucy's Weight Loss System is recalling Shorts on the Beach capsules because they contain undeclared Sibutramine, Phenolphthalein, and/or Diclofenac.

    Product
    Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1377-2016·2016-06-01

    Sausage Maker Seasoning Recalled for Undeclared Milk Ingredients

    The Sausage Maker, Inc. is recalling Dried Sausage Sticks seasoning because the Fermento ingredient contains undeclared whey protein and skim milk powder.

    Product
    THE SAUSAGE MAKER SEASONING Dried Sausage Sticks under the following labels: 1) Net Wt 6.5 oz, 2) Net Wt 2 lbs, 3) Net Wt 25 lbs, 4) Dried Sausage Stick Kit, 5) Dried Sticks Assortment Kit
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0864-2016·2016-06-01

    Baxter Recalls Clinimix E Bags Due to Dried Skin Particulate Matter

    Baxter Healthcare is recalling 7,436 bags of Clinimix E injection due to the presence of dried skin particulate matter. The product was distributed nationwide and in Puerto Rico.

    Product
    CLINIMIX E — CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide