The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

6151–6175 of 52958

  • HighFDA (Food)·F-0243-2025·2024-12-11

    Member's Mark Roasted Red Pepper Hummus Recalled for Potential Foreign Objects

    Cedar's Mediterranean Foods is recalling Member's Mark Roasted Red Pepper Hummus due to potential presence of foreign objects. The recall affects 23,136 units distributed to retail locations in ten states.

    Product
    Member's Mark brand Roasted Red Pepper Hummus; 32 oz (907 g) Plastic Container with UPC# 193968044268
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0608-2025·2024-12-11

    GE Healthcare CT Systems Recalled Due to Progressive Image Rotation

    GE Healthcare CT systems may display progressively rotated images, particularly in helical, cine, and cardiac scans. Rotations up to 56 degrees may affect image interpretation and could necessitate additional patient scanning.

    Product
    GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0239-2025·2024-12-11

    SYSCO Vanilla Instant recalled due to metal fragments in product

    SYSCO Vanilla Instant (24oz pouches, Lot 268 ECA) is recalled because a damaged sifter introduced metal fragments into the product. Consumers should not consume affected products.

    Product
    SYSCO VANILLA INSTANT, NET WT. 24OZ, Case UPC 10074865103791, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0640-2025·2024-12-11

    MEDLINE convenience kits recalled due to defective component

    Medline is recalling multiple lots of its convenience kits because they contain a component (SafeAir Smoke Evacuation Pencil) that was previously recalled by Stryker. The affected kits are distributed nationwide.

    Product
    MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q; 6) ZALE V-P SHUNT CDS, REF CDS983186J; 7) NEURO PACK-LF, R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0244-2025·2024-12-11

    Babcock Dairy Ice Cream Recalled for Undeclared Eggs and Yellow #5

    Babcock Dairy Chocolate Peanut Butter Ice Cream (half-gallon) is recalled due to undeclared eggs and yellow #5 dye. Consumers with egg allergies or yellow #5 sensitivity should not consume this product.

    Product
    Babcock Dairy Chocolate Peanut Butter Ice Cream, Half Gallon, University of Wisconsin-Madison. UPC 12316-01116.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0109-2025·2024-12-11

    Cinacalcet Tablets Recalled for Elevated Nitrosamine Impurity

    AvKARE is recalling 2,396 bottles of Cinacalcet Tablets 60 mg (Lot #44550) distributed nationwide due to CGMP deviations. The tablets contain N-Nitroso-Cinacalcet, a nitrosamine impurity, above acceptable intake limits.

    Product
    Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0080-2025·2024-12-11

    Venofer Iron Sucrose Injection Recalled for Potential Glass Contamination

    American Regent is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination from vials. The affected drug is distributed nationwide.

    Product
    VENOFER — VENOFER (IRON SUCROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0091-2025·2024-12-11

    Genuine Joe Antibacterial Lotion Soap recalled for manufacturing quality issue

    Midlab Incorporated is recalling Genuine Joe Antibacterial Lotion Soap (Lot 0711241) nationwide due to out-of-specification microbial test results found during manufacturing quality checks.

    Product
    Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0224-2025·2024-12-11

    Ellington Farms Lemonade Drink Mix recalled for metal fragment contamination

    Ellington Farms Lemonade Drink Mix is being recalled due to metal fragments introduced during dextrose production. No illnesses have been reported. The product was distributed to 29 states.

    Product
    ELLINGTON FARMS LEMONADE DRINK MIX NATURAL FLAVOR, Net Wt. 24 oz (1.5 lbs) 680g, UPC 0 46045 06155 2, Case UPC 50719098505490, Distributed by: Ben E. Keith Foods, Fort Worth, TX 76101
    Category
    Food
    Distribution
    30 states
  • HighFDA (Drugs)·D-0076-2025·2024-12-11

    Levothyroxine Sodium Tablets Recalled Due to Subpotency Nationwide

    Accord Healthcare is recalling Levothyroxine Sodium 75 mcg tablets (Lot D2300191, expiring 12/31/2025) distributed nationwide due to subpotency. Affected patients should contact their healthcare provider.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0089-2025·2024-12-11

    Array Liquid Antiseptic Handwash Recalled for Microbiological Test Failures

    Midlab Incorporated is recalling Array Liquid Antiseptic Handwash due to manufacturing quality deviations. The product failed microbiological testing and may not provide adequate antimicrobial protection.

    Product
    Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2025·2024-12-11

    X-ray system hand switch may fail, risking unintended radiation exposure

    Three Ziehm Vision x-ray systems have hand switches that may fail under mechanical stress, potentially causing unintended radiation. Owners should verify their serial numbers and contact the manufacturer.

    Product
    Ziehm Vision system, x-ray, tomography, computed.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0598-2025·2024-12-11

    Cartiva Synthetic Cartilage Implants Recalled Due to Higher Complication Rates

    Cartiva Synthetic Cartilage Implants are being recalled due to higher-than-expected rates of complications including implant displacement, subsidence, nerve damage, and fragmentation. Patients with these implants should consult their surgeon.

    Product
    Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0606-2025·2024-12-11

    CT imaging system issue causes progressive image rotation during scans

    GE Healthcare CT systems have a technical issue causing progressive image rotation during helical and cardiac scans. No injuries reported, but unnoticed rotation could affect diagnosis or require rescans.

    Product
    GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0595-2025·2024-12-11

    BACTEC 9120 System Recalled Due to Compromised Service Credentials

    BD recalled BACTEC 9120 Systems because technical support credentials were compromised by an unauthorized actor. Until credentials are updated, there is a risk of unauthorized access to the devices and associated data.

    Product
    BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0098-2025·2024-12-11

    Diltiazem Hydrochloride Capsules Recalled Due to Nitrosamine Impurity

    Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride capsules because they contain a chemical impurity above safe limits. About 7,296 bottles were distributed nationwide.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0101-2025·2024-12-11

    Duloxetine Capsules recalled for manufacturing impurity exceeding FDA interim limit

    Amerisource Health Services LLC is recalling 8,561 bottles of Duloxetine Delayed-Release Capsules, 60 mg due to N-nitroso-duloxetine impurity above recommended interim limits. The affected lots were distributed in Pennsylvania, Ohio, and Puerto Rico.

    Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Food)·F-0226-2025·2024-12-11

    Gordon CHOICE Lemonade Mix Recalled for Metal Fragment Contamination

    Gordon CHOICE Lemonade Beverage Mix is being recalled for metal fragment contamination in the product. Consumers should stop using affected packages and contact the manufacturer.

    Product
    Gordon CHOICE Lemonade Beverage Mix Naturally Flavored Low Calorie Instant LOW CAL LEMONADE, NET WT. 8.6 OZ (243 g), UPC 0 93901 59605 5, Case UPC 10093901596052, FOR DISTRIBUTION EXCLUSIVELY BY PARA SU DISTRIBUCION EXCLUSIVA POR GORDON FOOD SERVICE WYOMING, MI 49509
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0593-2025·2024-12-11

    BD BACTEC FX Instrument Top credential compromise enables unauthorized access risk

    BD service credentials for BACTEC FX instruments were accessed by an unauthorized actor, creating risk of unauthorized system access until credentials are updated.

    Product
    BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0610-2025·2024-12-11

    GE Healthcare Revolution Maxima CT Systems Recalled for Progressive Image Rotation

    GE Healthcare recalled Revolution Maxima and related CT imaging systems that can produce progressively rotated images during helical, cine, and cardiac scans. Approximately 72 units worldwide are affected; no patient injuries reported.

    Product
    GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0229-2025·2024-12-11

    Pink Lemonade Drink Mix Recalled for Metal Fragment Contamination

    REJUV ORIGINALS pink lemonade drink mix is being recalled due to metal fragments introduced during production. The contamination resulted from a damaged sifter used in dextrose processing.

    Product
    REJUV ORIGINALS PINK LEMONADE DRINK MIX NATURAL FLAVOR, NET WT. 24OZ. (680g), UPC 8 22486 11808 2, Case UPC 30822486118083, MARKETED BY INDEPENDENT MARKETING ALLIANCE HOUSTON, TX 77043
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0574-2025·2024-12-11

    X-ray system hand switch may fail under mechanical stress

    The Ziehm Solo FD interventional fluoroscopic x-ray system's hand switch may fail when exposed to mechanical stress, potentially causing unintended radiation. Twenty-five units are affected in the U.S. and Puerto Rico.

    Product
    Ziehm Solo FD. Interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0240-2025·2024-12-11

    THIRSTER Lemonade Drink Mix Recalled for Metal Fragment Contamination

    DYMA Brands recalls THIRSTER Lemonade Drink Mix because a damaged sifter used in dextrose production introduced metal fragments into the product. The product was distributed to 29 states.

    Product
    THIRSTER Lemonade Drink Mix NATURALLY FLAVORED LOW CALORIE, NET WT. 8.6 OZ (244 g), UPC 7 58108 39736 4, Case UPC 50758108397359, DISTRIBUTED BY US FOODS, INC. ROSEMONT, IL 60018
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0235-2025·2024-12-11

    Vanilla Pudding Mix Recalled Due to Metal Fragment Contamination

    Sysco Classic Vanilla Instant Pudding & Pie Filling Mix is recalled for metal fragments found in the product due to a damaged sifter used during dextrose production.

    Product
    Sysco Classic Vanilla Instant Pudding & Pie Filling Mix Natural and Artificial Flavor, NET WT. 32 OZ (2 LB) 907g, UPC 0 74865 20116 2, Case UPC 10074865201169, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0604-2025·2024-12-11

    CT imaging systems may display progressively rotated images in certain scan modes

    Certain GE Healthcare CT systems may display progressively rotated images, particularly during helical, cine, or cardiac scans. The rotation increases with each image, potentially reaching 56 degrees maximum.

    Product
    GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
    Category
    Medical Device
    Distribution
    0 states