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.

19351–19375 of 88183

  • ModerateFDA (Devices)·Z-1373-2023·2023-04-19

    Titan Penile Prosthesis Recalled Due to Premature Pump Failure Risk

    Coloplast Manufacturing is recalling the Titan 0-Deg Scrotal 18 Cm inflatable penile prosthesis (25 units) due to decreased wall thickness that may cause premature pump failure. Patients with affected lot numbers should contact their healthcare provider.

    Product
    Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0756-2023·2023-04-19

    Magnesium Citrate Tribasic Hydrate Powder Recalled for Microbial Contamination

    Jost Chemical Co is recalling Magnesium Citrate Tribasic Hydrate powder due to elevated microbial counts above the manufacturer's specification. Lot 25350037 (3,300 pounds) was distributed to Florida.

    Product
    Magnesium Citrate Tribasic Hydrate, USP, Ultrafine Powder sold in bulk 55 lb fiber box.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0716-2023·2023-04-19

    Hiland Fat Free Chocolate Milk Recalled Due to Food Grade Sanitizer Contamination

    Hiland Dairy Foods Company is recalling Hiland Fat Free Chocolate Milk Vitamin A&D sold in Texas. A small number of cartons may contain food grade sanitizer residue.

    Product
    Hiland Fat Free Chocolate Milk Vitamin A&D Naturally Flavored Half Pint (236 mL) UPC 72060 00133 4 packaged in a paper carton
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0529-2023·2023-04-19

    Drug Injection Recall: Norepinephrine Bitartrate Impurity Above Specification

    Sun Pharmaceutical is recalling Norepinephrine Bitartrate Injection due to a chemical impurity exceeding specification limits detected during routine monitoring. The recall affects 16,450 vials distributed nationwide.

    Product
    NOREPINEPHRINE BITARTRATE — NOREPINEPHRINE BITARTRATE (NOREPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0713-2023·2023-04-19

    Frisch's Tuna Salad Recalled Due to Condensation Contamination

    FKC LLC is recalling Frisch's Tuna Salad in 4-pound tubs distributed in Ohio, Kentucky, and Indiana due to condensation observed falling into the food.

    Product
    Frisch's Tuna Salad packaged in 4lb plastic tubs - sold individually
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0709-2023·2023-04-19

    Perrona Hot Sauce Recalled Due to Mold Growth on Bottle Exterior

    TIPPCON LLC is recalling Perrona Hot Sauce Original with Chiltepin Peppers due to mold growth on the outside of the bottle. The affected product was distributed nationwide.

    Product
    Perrona Hot Sauce Original with Chiltepin Peppers 5 fl oz (148ml) UPC 75 03016 55507 4 packaged in a PET bottle, 12 bottles per case
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0531-2023·2023-04-19

    Bevacizumab Injection Recall Due to Incorrect Lot Number Labeling

    Pine Pharmaceuticals is recalling 932 syringes of Bevacizumab 2.5 mg/0.1 mL due to incorrect lot number labeling on the primary packaging. The affected lot (#66377, expiration 06/28/2023) was distributed nationwide.

    Product
    Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually labeled poly envelopes (primary packaging). Repackaged by Pine Pharmaceuticals, Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1381-2023·2023-04-19

    NanoKnife Surgical Probes Recalled Due to RFID Programming Error

    Angiodynamics recalls NanoKnife 5-Probe Procedure Packs due to a programming error affecting RFID function. The probes may not be recognized by the NanoKnife generator, potentially delaying surgical procedures.

    Product
    NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1374-2023·2023-04-19

    Inflatable Penile Prosthesis Titan Recalled Coloplast Manufacturing Class II

    Coloplast Manufacturing recalls 20 units of Titan 0-Deg Scrotal inflatable penile prosthesis (Lot Numbers 8849601, 8849600, 8849621) with worldwide distribution. The specific reason for the recall is not specified in FDA records.

    Product
    Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0532-2023·2023-04-19

    Prescription Drug Recall: Incorrect Expiration Date on MEKTOVI Labels

    Pfizer recalls 1,926 bottles of MEKTOVI (binimetinib) due to incorrect expiration dates on labels. Bottles labeled March 2026 actually expire February 2025.

    Product
    MEKTOVI — MEKTOVI (BINIMETINIB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0530-2023·2023-04-19

    Pantoprazole Sodium Tablets Recalled for CGMP Deviations and Discoloration

    Hetero USA Inc. is recalling 2,352 bottles of Pantoprazole Sodium 40mg tablets due to manufacturing deviations that caused discoloration. The affected lot (PAN22542, exp. 9/2024) was distributed nationwide.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0710-2023·2023-04-19

    Perrona Hot Sauce Black Recalled Due to Mold Growth

    TIPPCON LLC is recalling Perrona Hot Sauce Black with Chiltepin Peppers due to mold growth detected on the outside of the bottle. No illnesses have been reported.

    Product
    Perrona Hot Sauce Black with Chiltepin Peppers Net 5 FL OZ (148 mL) UPC 75 03016 55511 1 packaged in a PET bottle, 12 bottles per case
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0535-2023·2023-04-19

    Prescription Epinephrine Kits Recalled for Incorrect NDC Number on Carton

    Focus Health Group is recalling 246 kits of Epinephrine Professional nationwide due to an incorrect NDC number printed on the outer carton. The labeling error does not affect the drug's safety or effectiveness.

    Product
    EPINEPHRINE PROFESSIONAL — EPINEPHRINE PROFESSIONAL (EPINEPHRINE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0711-2023·2023-04-19

    Perrona Hot Sauce Green Recalled Due to Mold Growth on Bottle Exterior

    TIPPCON LLC is recalling Perrona Hot Sauce Green with Chiltepin Peppers due to mold growth on the outside of the bottle. Approximately 8,230 cases were distributed nationwide.

    Product
    Perrona Hot Sauce Green with Chiltepin Peppers Net 5 FL OZ (148 mL) UPC 7 503016 555098 packaged in a PET bottle, 12 bottles per case
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0692-2023·2023-04-12

    Sysco Imperial Caesar Dressing Recalled for Egg Allergen Labeling Discrepancy

    Sysco Imperial Caesar Dressing recalled due to labeling discrepancy. The outer case label indicates the product contains eggs, but the primary product label does not list eggs as an ingredient.

    Product
    Sysco Imperial Caesar Dressing NET CONTENTS 1 GAL (3.78 l) INGREDIENTS: Soybean Oil, Water, Distilled Vinegar, Parmesan Cheese***High Fructose Corn Syrup, Salt, Contains less than 2% of Ground Mustard, Spice, Dried Garlic, Anchovy Paste***Sodium Benzoate***Calcium Disodium…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1288-2023·2023-04-12

    Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen

    The Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen during high-concentration therapy due to accuracy deviations. The device's internal oxygen sensor may also display incorrect readings, creating a risk of oxygen under-delivery to patients.

    Product
    Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200X15B, GB2200X15B, EU2200X15B, EU2200X19, EE2200X15B…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1273-2023·2023-04-12

    FreeStyle Libre Readers recalled due to lithium-ion battery fire hazard

    FreeStyle Libre Reader batteries may swell, overheat, or create fire hazard. Do not use if the device is damaged, cracked, swollen, excessively hot, won't hold charge, or fails Reader Test.

    Product
    FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1287-2023·2023-04-12

    Portable Electric Ventilators May Deliver Insufficient Oxygen During High-Concentration Therapy

    Philips Respironics ventilators may deliver oxygen below required tolerance during high-concentration therapy. The FiO2 sensor may display higher readings than actual delivery, risking insufficient oxygen to patients.

    Product
    Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1289-2023·2023-04-12

    Philips Trilogy Evo Portable Ventilators Recalled for Inaccurate Oxygen Delivery

    Philips Respironics is recalling the Trilogy Evo Universal Portable Electric Ventilator (Model DS2000X11B) because it may deliver oxygen below the prescribed level during high-concentration oxygen therapy, potentially depriving patients of adequate oxygen.

    Product
    Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0732-2023·2023-04-12

    Gerber GoodStart SoothePro infant formula recalled due to possible Cronobacter contamination

    Perrigo Nutritionals is recalling Gerber GoodStart SoothePro infant formula due to potential Cronobacter contamination. The recall affects 182,888 cans distributed nationwide and in Canada.

    Product
    Gerber GoodStart SoothePro Infant Formula with Iron. Milk Based Powder. Stage 1, 0 - 12 Months. Nestle Infant Nutrition, Arlington, VA 22209. Packaged in the following sizes: 1. Net Wt 12.4 oz. (351 g) (6 cans per case) UPC 050000-62400 3 2. Net Wt 30.6 oz. (1.91 lb…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1274-2023·2023-04-12

    FreeStyle Libre Readers Recalled for Battery Swelling and Fire Hazard

    Abbott is recalling over 1.3 million FreeStyle Libre Readers nationwide due to lithium-ion battery swelling, overheating, and fire hazards. Users should stop use if devices show damage, swelling, or excessive heat.

    Product
    FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0697-2023·2023-04-12

    Clio Strawberry Granola & Yogurt Parfait Bars Recalled Due to Listeria Risk

    Clio Strawberry Granola & Yogurt Parfait Bars (UPC 854021008152) are being recalled due to possible Listeria contamination. Affected products were distributed to retail stores in Iowa, Illinois, Virginia, Wisconsin, and North Carolina.

    Product
    Clio Strawberry Granola & Yogurt Parfait Bar Net Wt. 1.94 OZ (55g ) UPC: 854021008152 Packaged in a cardboard box.
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1322-2023·2023-04-12

    Philips DreamStation respiratory devices recalled for communication issues affecting prescription settings

    Philips DreamStation BiPAP and CPAP devices may experience communication failures with their cloud care management system, potentially preventing proper prescription settings from being downloaded to the device.

    Product
    Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0691-2023·2023-04-12

    Peanut Butter Pie Recalled Due to Potential Salmonella Contamination

    Desserts by Helen, Inc. is recalling Peanut Butter Pie due to potential contamination from JIF peanut butter manufactured during a recall period in 2022. The recall affects products distributed in Indiana, Kentucky, and Ohio.

    Product
    Peanut Butter Pie, 1 count
    Category
    Food
    Distribution
    3 states