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.

17026–17050 of 53124

  • HighFDA (Drugs)·D-1111-2022·2022-06-15

    Sumatriptan Succinate tablets recalled due to manufacturing temperature deviations

    McKesson Medical-Surgical is recalling Sumatriptan Succinate 100 mg tablets due to temperature abuse during manufacturing that may affect quality. Consumers should consult their physician or pharmacist about whether they have an affected product.

    Product
    SUMATRIPTAN SUCCINATE — SUMATRIPTAN SUCCINATE (SUMATRIPTAN SUCCINATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1251-2022·2022-06-15

    Medical Device Test Strip Recall: Potential False Negatives for Respiratory Pathogens

    NeuMoDx Flu A-B/RSV/SARS-CoV-2 test strips may produce false negative results for low viral loads, delaying diagnosis and treatment. The recall affects 459 U.S. kits and 1,626 international kits.

    Product
    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
    Category
    Medical Device
    Distribution
    10 states
  • HighNHTSA·22V424000·2022-06-15

    2022 Kenworth T180 ABS warning light malfunction recall

    PACCAR is recalling certain 2022 Kenworth T180 and 2023 Kenworth T280 and Peterbilt 535 vehicles because the ABS warning light may not illuminate during an ABS malfunction, potentially increasing crash risk. Dealers will provide a free software update.

    Product
    PETERBILT — PETERBILT, KENWORTH 535, T180, T280
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1063-2022·2022-06-15

    MethyLPREDNISolone Acetate Suspension Recalled for Temperature Abuse

    Mckesson Medical-Surgical is recalling MethyLPREDNISolone Acetate Injectable Suspension due to temperature-abuse cGMP deviations affecting 363 vials distributed nationwide.

    Product
    MethyLPREDNISolone Acetate Injectable Suspension, USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple Dose Vial, Rx only, MFG: NorthstarRx/Teva Pharma USA, NDC 16714-090-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1115-2022·2022-06-15

    Prescription anesthetic Diprivan recalled for manufacturing temperature deviation

    McKesson is recalling Diprivan (Propofol) injection due to manufacturing temperature deviations that may affect drug stability. The FDA Class II recall involves 122 cartons distributed nationwide to medical settings.

    Product
    DIPRIVAN — DIPRIVAN (PROPOFOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2022·2022-06-15

    Siemens Sensis Diagnostic Computer: Software Issues May Prevent Treatment Continuation

    Siemens has identified three potential software issues in Sensis programmable diagnostic computers. The issues may prevent treatment from continuing on the device, requiring patients to switch to alternate systems.

    Product
    Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1000-2022·2022-06-15

    Bupivacaine HCl Injection Recalled Due to Temperature Abuse Manufacturing Defect

    Bupivacaine HCl Injection multi-dose vials are being recalled due to temperature abuse during manufacturing. The product was distributed nationwide. Patients should consult their healthcare provider for alternative treatments.

    Product
    Bupivacaine HCl Injection, Multi dose vial, 0.25%, 50 mL/2.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0249-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1262-2022·2022-06-15

    Valencian Almonds with Truffle Recalled for Foreign Materials

    Valencian Almonds with Truffle distributed in bulk cases are being recalled due to potential foreign materials. The firm-initiated recall affects 60 cases distributed in Oregon.

    Product
    Valencian Almonds with TRUFFLE FS distributed in bulk case, each case contains 2/11 lbs. bags. Net Wt. per case 22 lbs. Product is shelf stable. The label of the bulk case is read in parts: "***Matiz MZ522 ***Valencian Almonds with TRUFFLE FS ***5 KG Skinless*** Net Wt. 352…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1025-2022·2022-06-15

    Amoxicillin capsules recalled due to temperature exposure during manufacturing

    McKesson Medical-Surgical is recalling Amoxicillin 500mg capsules distributed nationwide due to temperature abuse during manufacturing that may compromise product potency and effectiveness.

    Product
    AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1037-2022·2022-06-15

    Meclizine Hydrochloride Tablets Recalled for Manufacturing Temperature Control Deviations

    Mckesson Medical-Surgical is recalling Meclizine Hydrochloride 25mg tablets nationwide due to manufacturing deviations involving improper temperature control. The FDA classified this as a Class II recall.

    Product
    MECLIZINE HYDROCHLORIDE — MECLIZINE HYDROCHLORIDE (MECLIZINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0986-2022·2022-06-15

    FDA Recalls Ethanol Injection Vials Due to Sterility Concerns

    US Specialty Formulations is recalling 781 vials of Ethanol for Injection 95% due to lack of assurance of sterility. The product was distributed nationwide to medical facilities and physician offices.

    Product
    Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0987-2022·2022-06-15

    B-Complex plus Chromic Chloride injection recall for lack of sterility assurance

    US Specialty Formulations is recalling B-Complex plus Chromic Chloride injectable vials due to lack of assurance of sterility. The product was distributed to medical facilities and physician offices nationwide.

    Product
    B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1152-2022·2022-06-15

    Dutch Treat and Craftology Pasta Salad Recalled Due to Metal Contamination

    Craftology LLC and Dutch Treat Foods are recalling Sweet Pea and This Is My Happy Place pasta salads due to metal contamination in the bacon ingredient. Products were distributed in Michigan.

    Product
    Dutch Treat Foods Sweet Pea Pasta Salad, 10lbs food service case only, UPC 8-81399-00007-5. Craftology This Is My Happy Place Pasta Salad, 14oz. UPC 8-55034-00649-4; 6 x 14oz. per case UPC 8-55034-00657-9
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1082-2022·2022-06-15

    Prescription Thrombin Product Recalled for Temperature Storage Deviations

    McKesson is recalling RECOTHROM (Thrombin Topical Recombinant) because products were subjected to temperature abuse during storage or distribution, causing a cGMP (manufacturing practice) deviation.

    Product
    RECOTHROM — RECOTHROM (THROMBIN TOPICAL RECOMBINANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1018-2022·2022-06-15

    Albuterol sulfate inhalation solution recalled for manufacturing temperature-abuse defect

    McKesson Medical-Surgical is recalling albuterol sulfate inhalation solution 0.021% (0.63 mg/3mL vials) distributed nationwide. The FDA Class II recall is due to cGMP deviations involving temperature abuse.

    Product
    ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2022·2022-06-15

    Surgical needle electrode tip detachment risk during gastroenterology procedures

    ROi CPS LLC is recalling a sterile surgical needle used in gastroenterology bypass procedures because the electrode tip may detach during use. The recall affects 125 units distributed in North Carolina.

    Product
    Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-1055-2022·2022-06-15

    Ibuprofen tablets recalled nationwide due to temperature abuse during manufacturing

    McKesson Medical-Surgical is recalling Ibuprofen 400 mg prescription tablets nationwide due to temperature abuse during manufacturing. The manufacturing deviation may affect drug stability and efficacy.

    Product
    IBUPROFEN — IBUPROFEN (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1060-2022·2022-06-15

    FDA Recalls Medroxyprogesterone Acetate Injectable Suspension for Temperature Abuse

    McKesson Medical-Surgical recalls 780 vials of medroxyprogesterone acetate injectable suspension nationwide due to temperature exposure during distribution that may affect medication stability.

    Product
    Medroxyprogesterone acetate injectable suspension, 150 mg/mL, 1 mL single dose vial, Rx only, MFG: NorthStarRx/Teva Pharma USA , NDC 16714-981-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1040-2022·2022-06-15

    FDA Recalls Ipratropium Bromide Inhalation Solution Due to Manufacturing Deviation

    McKesson Medical-Surgical is recalling Ipratropium Bromide Inhalation Solution nationwide due to current good manufacturing practice (cGMP) deviations involving temperature control. The FDA has classified this as a Class II recall.

    Product
    IPRATROPIUM BROMIDE — IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1275-2022·2022-06-15

    Baguette Super recalled for potential insect filth contamination

    GRUVIPA S.L. is recalling CB1101004 and CB1101005 BAGUETTE SUPER products distributed in Florida due to potential insect filth contamination.

    Product
    CB1101004 BAGUETTE SUPER and CB1101005 BAGUETTE SUPER (34 u.)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1103-2022·2022-06-15

    Ondansetron Tablets Recalled for Temperature Exposure During Storage

    McKesson is recalling Ondansetron Hydrochloride 8 mg tablets distributed nationwide due to temperature abuse during storage that may affect medication stability. Patients should contact their pharmacy or doctor.

    Product
    ONDANSETRON HYDROCHLORIDE — ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide