The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

13376–13400 of 27206

  • ModerateFDA (Drugs)·D-0215-2024·2024-01-10

    OTC Cough Medicine Recalled for Potential Water Contamination Risk

    Seaway Pharma Inc. recalled Premier Value Tussin Cough DM due to possible microbial contamination in manufacturing water. No contamination was found in finished products and no illnesses have been reported.

    Product
    Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0625-2024·2024-01-10

    Reverse Shoulder Joint Implant System Recalled for Mislabeling

    Encore Medical is recalling 17 Reverse Shoulder System e+ surgical implants (Lot 381P1167) due to mislabeling. Affected units were distributed nationwide to multiple states.

    Product
    Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0630-2024·2024-01-10

    KeySplint Hard Clear dental devices recalled for incorrect instructions

    Keystone Industries is recalling 336 units of KeySplint Hard Clear due to incorrect Instructions for Use packaged with the product. Affected units received KeySplint Soft instructions instead.

    Product
    KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0636-2024·2024-01-10

    Impella Connect medical device software portal disables unevaluated features

    Abiomed has disabled four features in the Impella Connect software portal because the FDA has not evaluated them for safety and effectiveness.

    Product
    Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0213-2024·2024-01-10

    Prescription Oral Solution Eprontia Recalled for Out-of-Specification Impurity

    Azurity Pharmaceuticals recalls Eprontia (topiramate) oral solution nationwide because routine stability testing found an out-of-specification impurity. The chemical defect raised concerns about the drug's purity and patient safety.

    Product
    EPRONTIA — EPRONTIA (TOPIRAMATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0624-2024·2024-01-10

    Serology ToRCH positive control specimen recalled for decreased HSV reactivity

    Randox Laboratories recalls SEROLOGY ToRCH lgM 2022 POSITIVE CONTROL (Lot 157SR) due to decreased HSV Type 1/2 reactivity when tested on the DiaSorin Liaison XL analyzer. The product was distributed in New York and West Virginia.

    Product
    SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-0597-2024·2024-01-03

    MEGADYNE MEGA SOFT Return Electrode Recalled Due to Reported Patient Burn Injuries

    Megadyne Medical Products is recalling its MEGA SOFT Universal Patient Return Electrode due to reports of patient burn injuries, including third-degree burns requiring intervention. The product is now limited to use in patients age 12 and older.

    Product
    Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0600-2024·2024-01-03

    Megadyne Patient Return Electrode Recalled Due to Serious Burn Injury Reports

    Megadyne Medical Products is recalling the MEGA SOFT Universal Plus Patient Return Electrode due to reports of serious burn injuries, including third-degree burns. The device should not be used in patients under 12 years old.

    Product
    Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0599-2024·2024-01-03

    Megadyne MEGA SOFT Return Electrode Recalled for Serious Burn Injuries

    Megadyne Medical Products is recalling approximately 2,312 MEGA SOFT Universal Plus Patient Return Electrodes due to reports of serious patient burn injuries, including third-degree burns. The product is now restricted to patients age 12 and older.

    Product
    Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0206-2024·2024-01-03

    Supplement Capsules Recalled for Undeclared Sildenafil Content Nationwide

    Magnum XXL 9800 capsules contain undeclared sildenafil and were marketed without FDA approval. The product was distributed nationwide via Amazon.

    Product
    Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7. Amazon's ASIN# B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0207-2024·2024-01-03

    Brut Classic Antiperspirant and Deodorant Recalled for Benzene Contamination

    Brut Classic Antiperspirant & Deodorant in 4 oz and 6 oz aerosol cans is being recalled due to benzene contamination. The recall affects all lots distributed in the United States and Canada.

    Product
    Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4 oz. (113g) aerosol cans (UPC 00827755070085, NDC 41595-7103-1) and b) 6 oz. (170g) aerosol cans (UPC 00827755070108, NDC 41595-7103-2), Distributed by Idelle Labs, Ltd. El Paso, TX 79912 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0209-2024·2024-01-03

    Sure Regular Antiperspirant Deodorant Aerosol Recalled for Benzene Contamination

    Sure Regular Antiperspirant Deodorant Aerosol (6 oz cans) sold nationwide in the US and Canada is being recalled due to benzene contamination. All lots expiring on or before August 2023 are affected.

    Product
    Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5518-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0561-2024·2024-01-03

    Medline Tracheostomy Care Kits Recalled for Sharp Brush and Bristle Detachment

    Medline is recalling 620,735 tracheostomy care kits because the brush component has a sharp edge that can puncture tubing and injure users, and bristles can detach during use.

    Product
    Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile; (2) Medline Tracheostomy Clean and Care Tray, REF DYND4061030, Sterile; (3) Medline Basic Tracheostomy Care Kit, REF CC3T4691A, Sterile; (4) Medli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0208-2024·2024-01-03

    Sure Unscented Deodorant Aerosol Recalled for Benzene Contamination

    Sure Unscented Deodorant Aerosol is being recalled nationwide due to benzene contamination. Consumers should stop using affected cans and contact the manufacturer.

    Product
    Sure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5517-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0598-2024·2024-01-03

    Megadyne Patient Return Electrodes Recalled Due to Serious Burn Risk

    Megadyne Medical Products recalls its MEGA SOFT Universal Dual Patient Return Electrode due to reports of severe burn injuries, including third-degree burns requiring medical intervention. Use is now restricted to patients age 12 and older.

    Product
    Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0562-2024·2024-01-03

    Medline Nursing Skills Kit: Tracheostomy Brush Sharp Edge and Bristle Defect

    Medline is recalling 172 Nursing Skills kits due to defects in the tracheostomy brush component. The brush has a sharp edge that can puncture tubing and cause user injury, and bristles may detach during use.

    Product
    (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0563-2024·2024-01-03

    Medline Nurse Training Kits Recalled for Sharp Tracheostomy Brush

    Medline Industries recalls 550 educational nurse training kits due to sharp edges on tracheostomy brush components that can puncture tubing or cause injury, and bristles that may detach during or before use.

    Product
    (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and (2) Nursing Tote Kit, SKU #EDUC5056A, Case UPC 40195327153695, Non-sterile, For Training Purposes Only, Not For Human Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0176-2024·2024-01-03

    Donepezil Hydrochloride tablets recalled for improper storage temperature

    Donepezil Hydrochloride 10mg tablets are recalled due to exposure to temperatures outside labeled storage conditions. The FDA classified this Class II recall due to potential effects on drug stability.

    Product
    DONEPEZIL HYDROCHLORIDE — DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0613-2024·2024-01-03

    Alinity ci-series System Control Module Software Performance Issues Recalled

    Abbott Laboratories is recalling 8,424 Alinity ci-series System Control Module units due to software performance issues that could produce erroneous test results. Affected systems are used in clinical laboratories throughout the United States and 90+ countries.

    Product
    Alinity ci-series System Control Module, REF: 03R70-01
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Drugs)·D-0202-2024·2024-01-03

    Prescription Inhalation Powder Recalled for Storage Temperature Deviation

    Cardinal Healthcare recalls batch 62002532 of Wixela Inhub inhalation powder nationwide due to CGMP deviations. Products were exposed to temperatures outside labeled storage conditions, potentially affecting product stability.

    Product
    WIXELA INHUB — WIXELA INHUB (FLUTICASONE PROPIONATE AND SALMETEROL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0614-2024·2024-01-03

    Medtronic SynchroMed II Pump May Fail to Resume Drug Delivery After MRI

    The Medtronic SynchroMed II pump may fail to resume drug delivery after MRI if electromagnetic interference triggers telemetry mode while the pump is alarming. This could interrupt essential medication delivery in patients.

    Product
    Medtronic SynchroMed II, Model 8637-20, Programmable pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0618-2024·2024-01-03

    Acumed RibLoc U Plus 90 Surgical Guide Recalled for Potential Breakage

    Acumed LLC recalls 513 RibLoc U Plus 90 surgical guides due to potential breakage during use. The device is used in orthopedic rib fixation procedures.

    Product
    RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a power system to compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0204-2024·2024-01-03

    FDA Recalls AnazaoHealth Injectable Vitamin Solution Due to Particulate Matter

    AnazaoHealth Corporation is recalling 3,363 vials of Thiamine HCl/Pyridoxine HCl injection solution nationwide due to the presence of particulate matter. Affected lots are identified by lot numbers and expiration dates listed by the FDA.

    Product
    Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset Road, Las Vegas, NV, NDC 72682-8721-3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0184-2024·2024-01-03

    Drug Recall: Hydralazine Hydrochloride Tablets Due to Improper Storage

    Cardinal Healthcare is recalling Hydralazine Hydrochloride tablets nationwide because products were exposed to temperatures outside labeled storage conditions due to manufacturing practice deviations.

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