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.

6251–6275 of 7443

  • CriticalFDA (Drugs)·D-921-2013·2013-09-04

    Bethel 30 capsules recalled for undeclared active ingredients

    Bethel Nutritional Consulting, Inc. is recalling Bethel 30 capsules because FDA analysis found undeclared sibutramine and phenolphthalein, making the product an unapproved new drug.

    Product
    Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1854-2013·2013-09-04

    Heeren Brothers Recalls Athena Cantaloupes Due to Listeria Contamination

    Heeren Brothers Produce is recalling Athena cantaloupes sold in Michigan after FDA testing found Listeria monocytogenes contamination.

    Product
    Cardboard BIN LABEL: 03808 LOT #: 09000101, MELON CANTALOUPE..., 80-90 CT , 07/22/13 cantaloupes themselves are not labeled.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-920-2013·2013-09-04

    Fresenius Kabi Recalls Magnesium Sulfate Injection Due to Glass Particulates

    Fresenius Kabi is recalling 15,625 vials of Magnesium Sulfate Injection, USP, 50% due to the presence of glass particulate matter.

    Product
    Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-922-2013·2013-09-04

    Hospira Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter

    Hospira is recalling 264,432 bags of 0.9% Sodium Chloride Injection because the product may contain fibrous material.

    Product
    0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1834-2013·2013-08-28

    Whole Foods Recalls Crave Brothers Les Freres Cheese for Listeria Risk

    Whole Foods Market is recalling Crave Brothers Les Freres cheese due to potential Listeria monocytogenes contamination, which can cause serious infections in vulnerable populations.

    Product
    Crave Brothers Les Freres cheese sold with labeling as: Les Freres, Crave Brothers Les Freres, Les Freres Wash Rind Product of USA, Crave Bros Les Freres, Crave Brothers Les Freres Cheese by Pound, Les Freres Crave Brothers, and Les Freres Crave Brothers PO-RK. Cheese was cut an
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1828-2013·2013-08-28

    NuGo Dark Mocha Non-Dairy Coffee Creamer Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling Dark Mocha Non-Dairy coffee creamer because it may contain undeclared milk, posing a risk to people with milk allergies.

    Product
    NuGo Dark Mocha, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1830-2013·2013-08-28

    NuGo Dark Peanut Butter Cup Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling Dark Peanut Butter Cups labeled as non-dairy because they may contain undeclared milk.

    Product
    NuGo Dark Peanut Butter Cup, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1833-2013·2013-08-28

    NuGo Slim Espresso Recalled for Undeclared Milk Allergen

    NuGo Nutrition HQ is recalling NuGo Slim Espresso Non-Dairy products because they may contain undeclared milk. Consumers with milk allergies should not consume the product.

    Product
    NuGo Slim Espresso, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1897-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical Corporation is recalling Nova Max Glucose Test Strips due to reports of false abnormally high glucose readings.

    Product
    Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1811-2013·2013-08-21

    Crave Brothers Petit Frere Cheese Recalled Over Listeria Investigation

    Crave Brothers is recalling Petit Frere with Truffles Cheese due to a multi-state Listeria monocytogenes investigation.

    Product
    Crave Brothers Farmstead Classics Petit Frere with Truffles Cheese, PF88T. Net Wt. 8 oz. (227g). Packaged in cheese paper and sold inside a wooden box. Eight 8 oz. wheels per case.
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-1807-2013·2013-08-21

    Gold Star Herring Fillets Recalled for Listeria Contamination

    Gold Star Smoked Fish Corp. is recalling RYBACKA WIES brand Herring Fillets in Oil due to Listeria monocytogenes contamination found by New York State sampling.

    Product
    RYBACKA WIES brand HERRING FILLETS IN OIL (MATJES SLEDZ W OLEJU), Net Wt. 17.6 oz. (500g), UPC 0 21143 24122 8, Distributed By Gold Star, Inc., Brooklyn, NY 11231 --- The product is vacuum packed in a sealed plastic package.
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-1805-2013·2013-08-21

    Brach's Chocolate Malted Milk Balls Recalled for Undeclared Peanuts and Brazil Nuts

    Ferrara Candy Company is recalling Brach's Chocolate Malted Milk Balls because they may contain undeclared peanuts and Brazil nuts.

    Product
    Chocolate malted milk balls packaged in 6 lbs. bags and each case contains 3 x 6 lbs. bags; BEST BY 04/17/14; BRCH CHOC
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1810-2013·2013-08-21

    Crave Brothers Petit Frere Cheese Recalled Due to Listeria Investigation

    Crave Brothers Farmstead Cheese is recalling Petit Frere Soft Ripened Cheese because of a multi-state Listeria monocytogenes investigation.

    Product
    Crave Brothers Farmstead Classics Petit Frere Soft Ripened Cheese, PF88. Net Wt. 8 oz. (227g). Packaged in cheese paper and sold inside a wooden box. Eight 8 oz wheels per case.
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Devices)·Z-1899-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical is recalling 721,810 Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings.

    Product
    Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1809-2013·2013-08-21

    Crave Brothers Farmstead Cheese Recalled Due to Listeria Investigation

    Crave Brothers Farmstead Cheese is recalling specialty cheese products while regulatory agencies investigate a potential Listeria monocytogenes contamination.

    Product
    Crave Brothers Farmstead Classics Les Freres Semi-Soft French Style Cheese, LF225. 2.5 lb wheel packaged in cheese paper. Two 2.5 lbs wheels in a case.
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-1793-2013·2013-08-14

    Olde Thompson Recalls Organic Oregano Due to Salmonella Risk

    Olde Thompson, Inc. is recalling Earth's Pride Organics Organic Oregano due to a Salmonella hazard. The product was distributed to 14 states in the Northeast and Mid-Atlantic regions.

    Product
    Earth's Pride Organics: Organic Oregano, 2.2 oz. Packaged at 12 units per case. Packaged in a glass jar with cork closure. Product labeling reads in part:"earth's pride organics PANTRY COLLECTION***ORGANIC OREGANO***NET WT. 2.2 OZ (62.4g)***DISTRIBUTED BY BJWC 25 RESEARCH D
    Category
    Food
    Distribution
    15 states
  • CriticalFDA (Drugs)·D-837-2013·2013-08-14

    Reumofan Plus tablets recalled for undeclared active pharmaceutical ingredients

    Reumofan Plus tablets are being recalled because they were marketed without an approved NDA/ANDA and may contain undeclared active ingredients.

    Product
    Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-833-2013·2013-08-14

    Lightning ROD capsules recalled for undeclared sildenafil analogue

    Chang Kwung Products is recalling Lightning ROD capsules because FDA analysis found an undeclared analogue of sildenafil, an unapproved new drug.

    Product
    Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-834-2013·2013-08-14

    Lightning ROD capsules recalled for undeclared sildenafil analogue

    Chang Kwung Products is recalling Lightning ROD capsules because FDA analysis found an undeclared analogue of sildenafil, making the product an unapproved new drug.

    Product
    Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1820-2013·2013-08-07

    DePuy LPS Lower Extremity Dovetail Intercalary Component Recall for Fracture Risk

    DePuy Orthopaedics is recalling LPS Lower Extremity Dovetail Intercalary components due to a potential for fracture under certain physiological loads.

    Product
    LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
    Category
    Medical Device
    Distribution
    17 states
  • CriticalFDA (Drugs)·D-828-2013·2013-08-07

    Green Planet Night Bullet Capsules Recalled for Unapproved Active Ingredients

    Green Planet Inc is recalling Night Bullet Capsules because they contain unapproved active ingredients for erectile dysfunction.

    Product
    Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1775-2013·2013-08-07

    Hagee Foods Recalls Black Bean Hummus Due to Listeria Risk

    Hagee Foods Inc. is recalling specific varieties of Black Bean Hummus due to potential contamination with Listeria monocytogenes. The products were distributed in Oregon and Washington.

    Product
    Penny's Black Bean Hummus 12 oz has UPC 7 49404 70200 3; Harbor Greens Black Bean Hummus 8 oz has UPC 7 49404 80515 5; Tacoma Boys Black Bean Hummus 8 oz has UPC 7 49404 90515 2.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1783-2013·2013-08-07

    Lipari Foods Recalls Wholey Shrimp Due to Salmonella Risk

    Lipari Foods is recalling Wholey peeled, cooked shrimp because it may be contaminated with Salmonella, which can cause serious infections in vulnerable populations.

    Product
    WHOLEY Shrimp, Farm Raised, Cooked, Peeled Deveined, Tail on, Ingredients: Shrimp, Salt and Sodium Tripolyphosphate..., ,Net Wt 1 LB (16 oz) , 399103 UPC Number: 094776074556; Product of Indonesia
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-1761-2013·2013-08-07

    El Campestre Seafood Ranchero Recalled for Undeclared Allergens

    El Campestre is recalling Seafood Ranchero because it contains undeclared eggs, soy, wheat, and crab extract.

    Product
    El Campestre Brand Seafood Ranchero. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"SEA FOOD RANCHERO***NET WT..10 LBS***DIST.BY EL CAMPESTRE DIST TEL (562) 505-7247***".
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1742-2013·2013-07-31

    Bergin Fruit and Nut Pistachios Recalled Due to Salmonella Risk

    Bergin Fruit and Nut Co is recalling pistachio products because Salmonella was found in the environment at the supplier, ARO Pistachio Inc.

    Product
    603684 PISTACHIOS S/I/S 12/10 OZ GOLD BAG, UPC 2052603684 600913 PISTACHIOS S/I/S 12/12 OZ BAGLINE, UPC 2052600913 600913.11 PISTACHIOS S/I/S 12/12 OZ BAGLINE AMAZON, UPC 2052600913 600913.07 PISTACHIOS S/I/S 12/12 OZ BAGLINE DISPLAY BOX, UPC 2052600913 600923.05 PIST
    Category
    Food
    Distribution
    15 states