The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

3401–3425 of 4878

  • SevereFDA (Drugs)·D-1296-2022·2022-07-27

    Ortiga mas Ajo Rey supplement recalled for undeclared diclofenac

    FDA recalls Ortiga mas Ajo Rey dietary supplement sold nationwide due to undeclared diclofenac. Product marketed as supplement contains pharmaceutical ingredient not listed on label.

    Product
    Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle and 60 capsules (400 mg c/u) in a bottle, Hecho en Mexico por: Omega Nutrition , Jorge Washington No. 108 Col. Las Americas, Hidalgo del Parral, Chihuahua. C.P
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1337-2022·2022-07-27

    FDA Recalls Launch Sequence Euphoria Capsules for Undeclared Tadalafil

    Launch Sequence Euphoria Capsules have been recalled because the product contains undeclared tadalafil, an unapproved active ingredient. The capsules were distributed nationwide in the USA and Canada.

    Product
    Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1502-2022·2022-07-27

    Panera Bread Southwest Corn Chowder Recalled for Undeclared Wheat

    Blount Fine Foods is recalling Panera Bread at Home Southwest Corn Chowder due to undeclared wheat. The product poses a health risk to consumers with wheat allergies or celiac disease.

    Product
    Panera Bread at Home Southwest Corn Chowder, 16 oz. (453 g)
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-1295-2022·2022-07-27

    Artri Ajo King Tablets Recalled Due to Undeclared Diclofenac

    The FDA is recalling Artri Ajo King tablets nationwide after finding they contain undeclared diclofenac, a prescription anti-inflammatory drug. Affected bottles (lot LTARTKNGOMG30220, expiring December 2025) were sold on Amazon.

    Product
    Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B092P4615M, UPC 7 501031 111190
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1338-2022·2022-07-27

    Launch Sequence Aphrodisia Capsules recalled for undeclared tadalafil

    Launch Sequence Aphrodisia Capsules contain undeclared tadalafil, making them an unapproved drug. The recall involves 500 4-count tins distributed nationwide in the USA and Canada.

    Product
    Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1389-2022·2022-07-27

    GE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal

    GE Healthcare anesthesia systems may have reversed oxygen and air transducer connections, potentially affecting proper gas delivery. 5,372 devices worldwide are affected.

    Product
    GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1501-2022·2022-07-27

    Blazos Pie Shoppe Products Recalled for Possible Salmonella Contamination

    Blazos Pie Shoppe is recalling peanut butter cream and chocolate peanut butter cream pie and cup products that may be contaminated with Salmonella.

    Product
    10 oz Blazos Pie Shoppe Peanut Butter Cream Cup (UPC 9438600085)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1500-2022·2022-07-27

    Blazos Pie Shoppe peanut butter cream pies recalled for possible Salmonella contamination

    Blazos Pie Shoppe is recalling 9-inch peanut butter cream pies possibly contaminated with Salmonella. The affected products with code dates 6/23 and 6/27 were distributed in Michigan.

    Product
    9-inch pie Blazos Pie Shoppe Chocolate Peanut Butter Cream Pie (UPC 9438600049) 9-inch pie Blazos Pie Shoppe Peanut Butter Cream Pie (UPC 9438600025)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1336-2022·2022-07-27

    Dietary supplement found to contain undeclared pharmaceutical drug tadalafil

    Launch Sequence Capsules dietary supplement recalled for containing undeclared tadalafil, an FDA-approved pharmaceutical ingredient. The product was marketed without required drug approval.

    Product
    Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1297-2022·2022-07-27

    Artri King Herbal Supplement Tablets Recalled Nationwide for Undeclared Medication

    Amazon is recalling Artri King herbal supplement tablets nationwide due to FDA laboratory findings of undeclared diclofenac, a pharmaceutical medication not listed on the label. The product was marketed without FDA approval.

    Product
    Artri King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B084KSV12L, UPC 7 501031 111190
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1413-2022·2022-07-20

    Wawa Cold Brew Coffee Recalled for Undeclared Peanut Allergen

    Wawa cold brew coffee pints are being recalled due to undeclared peanuts. Approximately 1,000 units were distributed in Delaware, Florida, Maryland, New Jersey, Pennsylvania, Virginia, and Washington DC.

    Product
    Wawa COLD BREW COFFEE***ONE PINT (473ML)***MADE WITH WAWA COLD BREW***Nutrition Facts***INGREDIENTS: CREAM, SKIM MILK, LIQUID SUGAR (SUGAR, WATER), CORN SYRUP, WHEY, COFFEE, GUAR GUM, LOCUST BEAN GUM, TARA GUM, CARAMEL COLOR CONTAINS: MILK*DISTRIBUTED BY WAWA, INC, WAWA, PA 19063
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1349-2022·2022-07-20

    CoolCurve+ Vacuum Applicator Recalled for Increased Paradoxical Hyperplasia Reports

    Zeltiq Aesthetics is voluntarily recalling CoolCurve+ ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia during 2019–2021, an adverse event involving abnormal fat growth at treatment sites.

    Product
    CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Drugs)·D-1187-2022·2022-07-20

    Morphine Sulfate Tablets Recalled for Label Mix-up Dosage Error

    Morphine Sulfate extended-release tablets (30 mg) distributed in Alabama were recalled due to a critical label mix-up where bottles labeled as 60 mg contain 30 mg, and bottles labeled as 30 mg may contain 60 mg.

    Product
    Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., New Brunswick NJ 08901 USA; Relabeled by: Bryant Ranch Prepack, Inc., Burbank, CA, 91504 USA, NDC: 63629-1088-01.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1414-2022·2022-07-20

    Favorite Day Lavender Shortbread Cookie Bites Recalled for Undeclared Egg and Soy

    J & M Foods is recalling Favorite Day Lavender Shortbread Cookie Bites for undeclared egg and soy lecithin. Consumers with allergies to these ingredients should not consume the product.

    Product
    Favorite Day Lavender Shortbread Cookie Bites Net Wt 7oz (198g) packaged in a purple bag and an inside silver flexible bag UPC 085239286098, 6 units per case
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-1428-2022·2022-07-20

    Natreve Vegan Protein Powder Recalled for Undeclared Milk Allergen

    Natreve Vegan Protein Powder (Lot# 46359 and 46360) is recalled nationwide due to an undeclared milk allergen.

    Product
    Natreve Vegan Protein Powder 10 servings, 13.1oz (371g), UPC 628831120003 18 servings, 1.47lbs/23.53oz (667g), UPC 628831110073
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1284-2022·2022-07-20

    Arti King tablets recalled for undeclared pharmaceutical ingredients

    Arti King Refozado con Ortiga y Omega 3 Tablets are recalled nationwide because FDA testing found undeclared diclofenac and dexamethasone. The product was marketed without FDA approval and should not be used.

    Product
    Arti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en Mexico por: "PLANTAS MEDICINALES DE MEXICO", Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800 Mexico, UPC 7 501031 111138
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1175-2022·2022-07-13

    CVS Health Magnesium Citrate Laxative Recalled for Bacterial Contamination

    CVS Health Magnesium Citrate SALINE LAXATIVE Oral Solution (1.745 g, Lemon Flavor, 10 FL OZ) is being recalled due to microbial contamination with Gluconacetobacter Liquefaciens. Approximately 98,958 bottles distributed nationwide are affected.

    Product
    CVS Health Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 30594 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1317-2022·2022-07-13

    Palindrome H Chronic Catheters Recalled for Potential Hub Leaking

    Palindrome H Chronic Catheters are being recalled due to a potential leaking condition in the catheter hub that may result in unanticipated fluid return during hemodialysis treatment. Affected units have been distributed worldwide.

    Product
    Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1390-2022·2022-07-13

    GE Mini Chocolate Gob with Peanut Butter Icing Recalled for Salmonella

    Giant Eagle brand mini chocolate gobs with peanut butter icing are being recalled due to potential Salmonella contamination from Jiff peanut butter used in manufacturing. The product was distributed in Pennsylvania.

    Product
    GE Bakery, Gob, Mini, Chocolate, Peanut Butter Icing
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1277-2022·2022-07-13

    COVID-19 nasopharyngeal sample collection tray recalled due to improper assembly

    American Contract Systems, Inc. recalls 274,400 COVID-19 test kits distributed in Minnesota due to off-site assembly by individuals who may not have been properly trained.

    Product
    Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1316-2022·2022-07-13

    Palindrome Chronic Catheter recalled due to potential hub leakage

    Covidien is recalling Palindrome Chronic Catheters due to a potential leaking condition in the hub that may cause unexpected fluid return during use.

    Product
    Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1276-2022·2022-07-13

    Clean Catch Urine Kit Recalled Due to Improper Assembly

    American Contract Systems is recalling 274,400 Clean Catch Urine Kits due to improper assembly by potentially untrained individuals. The FDA classified this as a Class I recall.

    Product
    Clean Catch Urine Kit NS 178489, AHMU58A
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1388-2022·2022-07-13

    Organic oregano ground recalled due to Salmonella contamination

    OS Holding Inc is recalling Organic Oregano Ground distributed in Arizona, Minnesota, and Wisconsin due to potential Salmonella leeuwarden contamination.

    Product
    Organic Oregano Ground is packed in bulk 35 lbs. cases with food-grade poly bag that is labeled in parts: "OREGONSPICE COMPANY***OG Oregano Ground***Net Wt 35 lb (15.89 kg)***13320 NE Jarrett St.*Portland, Oregon 97230***".
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1312-2022·2022-07-13

    Palindrome Precision Chronic Dialysis Catheter Hub Leak Risk

    Palindrome Precision Chronic Catheters used for dialysis may leak due to a flaw in the hub component, potentially allowing unintended fluid to escape during treatment.

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