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.

5576–5600 of 7443

  • CriticalFDA (Drugs)·D-1328-2014·2014-05-28

    Pfizer Recalls Effexor XR Capsules Due to Foreign Tablet Contamination

    Pfizer is recalling specific lots of Effexor XR 150 mg capsules because a foreign Tikosyn capsule was found in a bottle.

    Product
    Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of Use bottles (NDC 0008-0836-21) UPC 3 0008-0836-21 7; b) 90-count Unit of Use bottles (NDC 0008-0836-22) UPC 3 0008-0836-22 4; Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subs
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1333-2014·2014-05-28

    Herbal Give Care Recalls Esbelder Fem Supplement for Undeclared Sibutramine

    Herbal Give Care Llc is recalling Esbelder Fem Mezcla con L-Carnitina because it contains undeclared sibutramine, a drug removed from the U.S. market for safety reasons.

    Product
    Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle, Hecho en Mexico: Soluciones HGC S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000251
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1329-2014·2014-05-28

    Esbelin Siloutte Mezcal Herbal Recalled for Undeclared Sibutramine

    Herbal Give Care Llc is recalling Esbelin Siloutte Mezcal Herbal because it contains undeclared sibutramine, a drug removed from the U.S. market for safety reasons.

    Product
    Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho En Mexico Por: Soluciones HGC S. de R.L. de C.V. Av. Independicia #1016 Frac. La Rinconada Aguascalientes, Ags. Mex C.P. 20136, UPC 7502011000060
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1539-2014·2014-05-28

    Fisher & Paykel Recalls Infant Nasal CPAP Prongs for Detachment Risk

    Fisher & Paykel Healthcare is recalling infant nasal CPAP prongs and starter kits because the prongs may detach from the tubing, interrupting therapy.

    Product
    Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1338-2014·2014-05-28

    Magic For Men Recalled for Undeclared Sildenafil and Tadalafil

    Schindele Enterprises is recalling Magic For Men dietary supplements because they contain undeclared sildenafil and tadalafil without FDA approval.

    Product
    Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manufactured For: BTQ Ski, Inc., Chicago, IL 60638
    Category
    Drug
    Distribution
    13 states
  • CriticalFDA (Drugs)·D-1330-2014·2014-05-28

    Herbal Tea Recalled for Undeclared Sibutramine and Related Compounds

    Herbal Give Care Llc is recalling Esbelin Siloutte Te herbal tea because it contains undeclared sibutramine and related compounds, making it an unapproved new drug.

    Product
    Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea in a gold foil/plastic zip-lock pouch. Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7562684652553
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1346-2014·2014-05-28

    Naturect Capsules Recalled for Undeclared Tadalafil Ingredient

    Tendex is recalling Naturect Capsules because FDA analysis found the product contains undeclared tadalafil, making it an unapproved drug.

    Product
    NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1340-2014·2014-05-28

    XZEN Platinum Recalled for Undeclared Sildenafil and Tadalafil

    Schindele Enterprises is recalling XZEN Platinum dietary supplements because they contain undeclared sildenafil and tadalafil, which were marketed without FDA approval.

    Product
    XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA.
    Category
    Drug
    Distribution
    13 states
  • CriticalUSDA FSIS·032-2014·2014-05-23

    California Firm Recalls Beef Products Due to Undeclared Milk Allergen

    Chaparros Mexican Foods Inc. is recalling approximately 568,503 pounds of beef products because they contain undeclared hydrolyzed milk protein.

    Product
    California Firm Recalls Beef Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1929-2014·2014-05-21

    Fernandez Chile Molido Puro Recalled for Salmonella Contamination

    Fernandez Chile Company is recalling specific lots of chile products due to Salmonella contamination. Consumers in Colorado and New Mexico should check their pantries.

    Product
    Fernandez True Chile Flavor, Medium Hot Chile Molido Puro, 4 oz.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1948-2014·2014-05-21

    Purity Organic Fresh Mangoes Recalled for Listeria Monocytogenes

    Pacific Organic Produce is recalling Purity Organic Fresh Mangoes after an inspection sample tested positive for Listeria monocytogenes.

    Product
    Purity Organic - Organic Mango Mango Tommy Atkins CAT 1, Size 07, 08, 10 and 12. Product of Mexico, Pacific.com distributed by: Pacific Organic Produce, San Francisco, CA 94080
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-1932-2014·2014-05-21

    Fresh Express Italian Salad Recalled for Listeria Contamination

    Chiquita Brands International is recalling Fresh Express Italian salad due to Listeria monocytogenes contamination. The product was distributed in 15 states and DC.

    Product
    Fresh Express, Italian, Crunchy Romaine Lettuce and Red Cabbage Salad, 10oz clear plastic bags, UPC: 71279-21100.
    Category
    Food
    Distribution
    16 states
  • CriticalFDA (Drugs)·D-1322-2014·2014-05-21

    REUMOFAN PLUS Tablets Recalled for Undeclared Ingredients and Lack of Approval

    Pain Free By Nature is recalling REUMOFAN PLUS tablets because they were marketed without FDA approval and contain undeclared diclofenac and methocarbamol.

    Product
    REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalCPSC·14185·2014-05-20

    Bed Handles Inc. Recalls Portable Bed Handles Due to Entrapment Deaths

    Bed Handles Inc. is recalling about 113,000 portable bed handles sold without safety retention straps. Three deaths were reported after users became entrapped between the mattress and the shifting handles.

    Product
    Portable bed handles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1926-2014·2014-05-14

    Kroger Private Selection Sweet Strawberry Sorbet Recalled for Undeclared Milk

    Kroger is recalling Private Selection Sweet Strawberry Sorbet because it contains undeclared milk, posing a risk to consumers with milk allergies.

    Product
    PRIVATE SELECTION SWEET STRAWBERRY SORBET, Labeled in part: "INGREDIENTS: WATER, SUGAR***DISTRIBUTED BY, THE KROGER CO., CINCINNATI, OHIO 45232***SELL BY AUG 11 15 3948 00:48 LIA" 0 11110 52108 8
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-1925-2014·2014-05-14

    Archer Farms Chocolate Hazelnut Swirl Gelato Recalled for Undeclared Peanut

    Sinco Inc. is recalling Archer Farms Chocolate Hazelnut Swirl Gelato because it contains undeclared peanut protein.

    Product
    Archer Farms Brand Chocolate Hazelnut Swirl Gelato (Italian Ice Cream), 30 FL OZ. plastic tub, frozen. Product of Italy UPC 085239-703618
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1888-2014·2014-05-07

    Schwan's Recalls Holiday Foods Cold Canapes Due to Listeria Risk

    Schwan's Global Supply Chain is recalling Holiday Foods Gourmet Cold Canapes Assortment due to potential Listeria monocytogenes contamination from recalled ingredients.

    Product
    Holiday Foods Gourmet Cold Canapes Assortment, 4800361, UPC 70220748003616, 100 OCS. Keep Frozen, For Institutional Use Only, Defrost in Refrigerator for Approximately 3 hours Before Serving, Consume Immediately. Prepared by Holiday Foods Inc, Hollywood, Florida 33020.
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Drugs)·D-1269-2014·2014-05-07

    B. Braun Recalls Cefazolin Sodium Injectable Due to Particulate Matter

    B. Braun Medical Inc. is recalling Cefazolin Sodium injectable products because visible particulate matter was found in reserve sample units.

    Product
    CEFAZOLIN SODIUM — CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1273-2014·2014-05-07

    B. Braun Recalls TrophAmine Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling TrophAmine (10% Amino Acid Injection) units due to visible particulate matter found in reserve samples.

    Product
    TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-9341-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1276-2014·2014-05-07

    Baxter Recalls Dianeal Peritoneal Dialysis Solution Due to Mold Contamination

    Baxter Healthcare is recalling 27,169 containers of Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to reported leaks and mold contamination.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1277-2014·2014-05-07

    Dietary Supplement Recalled for Undeclared Fluoxetine and Lack of Approval

    Deseo Rebajar is recalling Adipotrim XT dietary supplements because FDA testing found undeclared fluoxetine and the product was marketed without an approved NDA/ANDA.

    Product
    Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1249-2014·2014-04-30

    JaDera Weight Loss Supplement Recalled for Undeclared Sibutramine

    Dolphin Intertrade Corporation is recalling JaDera weight loss capsules because they contain undeclared sibutramine, a drug removed from the U.S. market for safety reasons.

    Product
    JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1248-2014·2014-04-30

    Fossil Fuel Products Recalls RezzRX Capsules for Undeclared Ingredients

    Fossil Fuel Products, LLC is recalling RezzRX capsules because they contain undeclared hydroxylthiohomosildenafil and aminotadalafil.

    Product
    RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1471-2014·2014-04-30

    Heartware HVAD Pump Implant Kit Recalled for Driveline Connector Separation

    HeartWare Inc is recalling HVAD Pump Implant Kits because the driveline connector housing may separate. This defect could affect patients using the device for heart failure.

    Product
    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The Hear
    Category
    Medical Device
    Distribution
    Distributed nationwide