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.

17051–17075 of 53124

  • HighFDA (Drugs)·D-1119-2022·2022-06-15

    Intralipid Intravenous Fat Emulsion Recalled for Temperature Abuse

    McKesson Medical-Surgical is recalling Intralipid intravenous fat emulsion distributed nationwide due to cGMP deviations involving temperature abuse that could compromise product safety.

    Product
    INTRALIPID — INTRALIPID (I.V. FAT EMULSION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1121-2022·2022-06-15

    Bone Marrow Biopsy Tray with Lidocaine Hydrochloride Recalled for Temperature Abuse

    McKesson is recalling Bone Marrow Biopsy Trays with Lidocaine due to cGMP deviations from temperature abuse. Product was distributed nationwide.

    Product
    Biopsy and Aspiration Tray Bone Marrow Illinois 11GX4 (10/cs) Rx CRFPED Lidocaine Hydrochloride USP, 1%, 5mL, Rx only, MFG: Becton Dickinson
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2022·2022-06-15

    Endoscope models recalled for image loss during electrocautery activation

    Karl Storz endoscope models may lose image when monopolar electrocautery is activated. The recall affects 401 units distributed to hospitals in 33 U.S. states and Canada.

    Product
    STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1151-2022·2022-06-15

    Pasta Salad with Bacon Recalled Due to Metal Foreign Material

    Dutch Treat Foods, Lipari Old Tyme, and Craftology bacon pasta salad products are recalled due to metal fragments in the bacon. Products were distributed in Michigan.

    Product
    Dutch Treat Foods Sweet Bacon Bowtie Pasta Salad, 10lbs food service case only, UPC 8-81399-00022-8. Lipari Old Tyme Sweet Bacon Bowtie Pasta Salad, 10lbs food service case only, UPC 8-81399-00032-7. Craftology Bacon With Your Bowtie Pasta Salad, 14oz. UPC 8-55034-00650-0; 6 x…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1066-2022·2022-06-15

    Clonidine Hydrochloride Tablets Recalled Due to Temperature Abuse During Manufacturing

    FDA recalls 63 bottles of Clonidine Hydrochloride Tablets (0.1 mg, NDC 00228-2127-10) distributed nationwide due to temperature abuse causing cGMP deviations during manufacturing.

    Product
    Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottle, Rx only, MFG: Teva/Actavis, NDC 00228-2127-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1104-2022·2022-06-15

    Injectable Pantoprazole Sodium Recalled for Temperature Exposure During Manufacturing

    McKesson Medical-Surgical Inc. is recalling injectable Pantoprazole Sodium for Injection due to manufacturing deviations involving temperature abuse. The nationwide recall affects a 10-vial carton; no illnesses have been reported.

    Product
    Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only, MFG: Sandoz Pharma, NDC 0781-3232-95
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1041-2022·2022-06-15

    ClomiPHENE Citrate Tablets 50 mg Recalled Due to Temperature Abuse

    McKesson Medical-Surgical is recalling ClomiPHENE Citrate Tablets 50 mg due to temperature abuse during distribution. The medication was distributed nationwide; patients should contact their healthcare provider for guidance.

    Product
    ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pharma, NDC 49884-701-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2022·2022-06-15

    Centricity Cardiology CA1000 may display inaccurate distance and area measurements

    GE Healthcare is recalling the Centricity Cardiology CA1000 software due to potential inaccurate distance and area measurements on magnified or scaled-down images, which could affect diagnostic accuracy.

    Product
    Centricity Cardiology CA1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1100-2022·2022-06-15

    Verapamil HCL injection recalled due to temperature abuse during manufacturing

    McKesson Medical-Surgical is recalling Verapamil HCL injection ampules (NDC 04094-011-01) distributed nationwide due to temperature abuse during manufacturing.

    Product
    Verapamil HCL, ampule, 2.5 mg/ML 2ML (5/pack), Rx only, MFG: Pfizer, NDC 04094-011-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1095-2022·2022-06-15

    Bupivacaine Hydrochloride Injection Recalled Due to Manufacturing Temperature Deviations

    McKesson Medical-Surgical Inc. is recalling Bupivacaine Hydrochloride injections distributed nationwide due to manufacturing deviations involving temperature abuse that may have compromised the drug's potency and sterility.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1102-2022·2022-06-15

    Prescription eye ointment recalled for temperature storage deviations

    McKesson Medical-Surgical recalls Neomycin and Polymyxin B Sulfates and Dexamethasone ophthalmic ointment (120 tubes) nationwide due to temperature storage deviations during manufacturing.

    Product
    NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE — NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1058-2022·2022-06-15

    Sodium Bicarbonate Antacid Tablets Recalled for Manufacturing Temperature Abuse

    McKesson Medical-Surgical is recalling Sodium Bicarbonate Antacid Tablets nationwide due to temperature abuse during manufacturing. Consumers should consult their healthcare provider about continued use.

    Product
    SODIUM BICARBONATE ANTACID — SODIUM BICARBONATE ANTACID (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1070-2022·2022-06-15

    Methylprednisolone Acetate Injectable Suspension Recalled for Manufacturing Temperature Deviations

    McKesson Medical-Surgical is recalling Methylprednisolone Acetate Injectable Suspension nationwide due to temperature control violations in manufacturing. The affected product was distributed to healthcare providers across the United States.

    Product
    MethyLPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0031-01), b) 25-count box (NDC 0703-0031-04), Rx only, MFG: Teva Pharma USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1059-2022·2022-06-15

    Prescription Antibiotic Tablets Recalled Due to Temperature Abuse

    McKesson Medical-Surgical is recalling Sulfamethoxazole and Trimethoprim Tablets (800mg/160mg) nationwide due to cGMP deviations caused by temperature abuse during manufacturing.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1248-2022·2022-06-15

    Getinge CM320-2 Surgical Instrument Washer Disinfector Recalled for Incomplete Installation Verification

    Getinge recalls its CM320-2 washer disinfector due to unverified or incomplete installation, which could cause skin burns, electric shock, smoke inhalation, or crush injuries. Four units were distributed across seven US states.

    Product
    Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1050-2022·2022-06-15

    FDA Recalls Xylocaine MPF Injectable Due to Temperature Storage Deviations

    McKesson Medical-Surgical is recalling Xylocaine MPF (lidocaine and epinephrine injection) nationwide due to temperature abuse during storage that could affect drug quality. Healthcare providers should discontinue use and contact their supplier.

    Product
    Xylocaine - MPF (lidocaine HCl and epinephrine injection, USP), 1%, 300 mg/30 mL, single dose vial, 5-count box, Rx only, MFG: App Pharmaceuticals LLC, NDC 63323-0487-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1084-2022·2022-06-15

    FDA Class II Recall: E-Z-HD Barium Sulfate Oral Suspension Due to Temperature Abuse

    McKesson is recalling E-Z-HD (Barium Sulfate for Oral Suspension) due to temperature deviations during manufacturing. Healthcare providers should stop using the recalled product and contact the manufacturer for lot identification.

    Product
    E-Z-HD — E-Z-HD (BARIUM SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1264-2022·2022-06-15

    Bulk Peaches from Chile Recalled for Potential Listeria Monocytogenes Contamination

    Brookshire Grocery Co. is recalling 595 cases of bulk peaches from Chile (PLU 4044) due to potential Listeria monocytogenes contamination. The product was distributed in Texas, Arkansas, and Louisiana.

    Product
    yellow flesh bulk peaches product of Chile bulk approximately 16lbs. per case PLU 4044
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1062-2022·2022-06-15

    FDA Recalls MethyLPREDNISolone Acetate Injectable Suspension Over Temperature Abuse

    McKesson is recalling 263 vials of MethyLPREDNISolone Acetate Injectable Suspension (200 mg/5 mL) nationwide due to cGMP deviations involving temperature abuse.

    Product
    MethyLPREDNISolone Acetate Injectable Suspension, USP, 200 mg/5 mL (40 mg/mL), 5 mL Multiple Dose Vial, Rx only, MFG: NorthstarRx/Teva Pharma USA , NDC 16714-089-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1067-2022·2022-06-15

    Levalbuterol tartrate HFA inhalation aerosol recalled for temperature abuse

    Levalbuterol tartrate HFA inhalation aerosol is being recalled nationwide by McKesson Medical-Surgical due to temperature abuse during storage and distribution. The FDA has classified this as a Class II recall.

    Product
    LEVALBUTEROL TARTRATE HFA INHALATION — LEVALBUTEROL TARTRATE HFA INHALATION (LEVALBUTEROL TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1022-2022·2022-06-15

    Adrenalin epinephrine vials recalled nationwide due to temperature-abuse deviations

    McKesson Medical-Surgical is recalling Adrenalin (epinephrine) 30 mL vials nationwide due to cGMP deviations involving temperature abuse during manufacturing. Temperature excursions may compromise drug potency.

    Product
    ADRENALIN — ADRENALIN (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1076-2022·2022-06-15

    FDA Recalls Proair HFA Albuterol Inhalation Aerosol for Temperature Abuse

    The FDA recalled 56 units of Proair HFA (albuterol sulfate) inhalation aerosol due to temperature abuse during manufacturing. The affected products were distributed nationwide.

    Product
    Proair, HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 59310-579-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1079-2022·2022-06-15

    Vecuronium Bromide for Injection Recalled for Manufacturing Temperature Deviation

    McKesson Medical-Surgical is recalling Vecuronium Bromide for Injection (10 mg) manufactured by Teva Pharma USA due to cGMP deviations involving temperature abuse during production. The product was distributed nationwide; no illnesses have been reported.

    Product
    Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial, 10-count box, Rx only, MFG: Teva Pharma USA, NDC 0703-2914-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1247-2022·2022-06-15

    GMK Sphere CR Size 1 Instrument Set Assembly Defect Recall

    Medacta Usa Inc recalls GMK Sphere CR Insert Instrument Set Size 1 due to component assembly error: Size 2 trial baseplates were assembled with Size 1 instrument sets, potentially affecting surgical function.

    Product
    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
    Category
    Medical Device
    Distribution
    7 states