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.

13401–13425 of 88183

  • HighFDA (Devices)·Z-1705-2024·2024-05-08

    Zirconium oxide dental blocks recalled due to cracking and fracture risk

    IVOCLAR VIVADENT is recalling IPS e.max ZirCAD zirconium oxide blocks nationwide because they may develop cracks after sintering that could cause dental restorations to fracture in patients' mouths.

    Product
    IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2024·2024-05-08

    Intellis AdaptiveStim Spinal Cord Stimulator unable to reprogram

    Medtronic Neuromodulation recalls the Intellis AdaptiveStim spinal cord stimulator because one device cannot be reprogrammed. Patients should consult their healthcare provider.

    Product
    Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1206-2024·2024-05-08

    Longreen Corporation Reishi Coffee recalled for undeclared soy and coconut allergens

    BF Suma Pharmaceuticals is recalling Longreen Corporation 4 in1 Reishi Coffee because soy lecithin and coconut oil were not declared on the label. Consumers with soy or coconut allergies could have allergic reactions.

    Product
    Longreen Corporation 4 in1 Reishi Coffee, 18.2 grams/sachet, 10 sachets/box
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1245-2024·2024-05-08

    International Bread Pita Chips Recalled for Undeclared Wheat Allergen

    International Bread Pita Chips are being recalled because the product label lists flour as an ingredient but fails to disclose that wheat is a sub-ingredient of the flour, a major allergen.

    Product
    International Bread Pita Chips Retail Clamshell Container: 10oz., Bulk bag: 10lbs. Garlic Baked Pita Chips: 6 81942 22111 3
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1756-2024·2024-05-08

    Philips Spectral CT Oncology Imaging System Recall: Laser Reflection Hazard

    Philips recalls 12 units of its Spectral CT Oncology Essentials system because a marking laser could reflect off the gantry cover, potentially causing misdiagnosis and incorrect patient treatment.

    Product
    The Oncology Essentials Package of the Spectral CT imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1704-2024·2024-05-08

    Zirconium oxide dental blocks recalled due to cracking risk

    IVOCLAR VIVADENT AG is recalling 7,445 units of IPS e.max ZirCAD CER/in. Prime zirconium oxide blocks because they may crack during sintering, potentially causing dental restorations to fracture in patients' mouths.

    Product
    IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1753-2024·2024-05-08

    Hip Cup Removal Instrument Recalled Due to Wrong Blade Assembly

    Innomed is recalling the Cup Removal Starter Instrument due to a manufacturing error where the finisher blade was affixed instead of the starter blade. The wrong blade could compromise surgical performance during hip replacement procedures.

    Product
    INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Food)·F-1209-2024·2024-05-08

    Puerto Rican Wedding Cake Recall: Undeclared Food Dyes

    Reposteria Artesanal Laura is recalling Bizcocho de Boda Puertorriqueño cakes in Puerto Rico due to undeclared artificial food dyes (Red #40, Red #3, Yellow #5, Yellow #6, Blue #1, Blue #2).

    Product
    Bizcocho de Boda Puertorrique¿o Naked "Puerto Rican wedding cake naked", packaged in aluminum mold/plastic showcase, 24 Pack per case of 10 oz / 6 pack per case of 32 oz/ 4 pack per case of 51.2 oz, Net Wt. 10 oz UPC 851249003075, 32 oz. UPC 851249003112 and 52.2 oz UPC…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0478-2024·2024-05-08

    Injectable epinephrine-lidocaine recalled for failing potency specification

    Imprimis NJOF, LLC is recalling epinephrine-lidocaine injectables nationwide because they failed to meet potency specifications. Patients should contact their healthcare provider regarding affected lots.

    Product
    Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0481-2024·2024-05-08

    Prescription Valacyclovir Tablets Recalled Due to Missing Imprint

    Viatris Inc is recalling 143,230 bottles of Valacyclovir Hydrochloride 500 mg tablets due to missing imprints on some tablets. The recall is nationwide and affects two lot numbers expiring in June 2024 and May 2025.

    Product
    VALACYCLOVIR HYDROCHLORIDE — VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0480-2024·2024-05-08

    Fentanyl Injection Bags Recalled Due to Incorrect Barcode Labels

    Hikma Injectables USA Inc. has recalled 1,895 bags of Fentanyl 1000mcg/100mL injection (lot CH0324001) due to incorrect barcodes on the product labeling.

    Product
    Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1612-2024·2024-05-01

    Route 92 Medical 070 Access System Recalled for Distal Tip Separation Risk

    Route 92 Medical 070 Access System catheters are recalled for potential distal tip separation during neurovasculature procedures. The defect affects 117 units distributed across 30 US states and New Zealand.

    Product
    Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states
  • CriticalFDA (Drugs)·D-0459-2024·2024-05-01

    FDA Recalls Alcoholada Gel Pain Reliever Over Methanol Contamination

    Alcoholada Gel pain reliever is being recalled because the ethanol ingredient contains methanol contamination. The FDA classified this as a Class I recall affecting 9,625 bottles distributed nationwide.

    Product
    Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0451-2024·2024-05-01

    Samurai-X Honey 6800 Recalled for Undeclared Drug Ingredients

    Samurai-X Honey 6800, manufactured by Pyramids Wholesale Inc., is recalled for containing undeclared sildenafil and/or tadalafil. The product was distributed nationwide and marketed without FDA drug approval.

    Product
    Samurai-X Honey 6800, UPC 2 56891 27553 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0457-2024·2024-05-01

    Male Performance Enhancer Recalled for Undeclared Sildenafil and Tadalafil

    ALPHASTRIP Male Performance Enhancer strips are being recalled nationwide because they contain undeclared sildenafil and tadalafil. The product was marketed without FDA approval.

    Product
    ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0449-2024·2024-05-01

    Honey product recalled nationwide for undeclared sildenafil and tadalafil

    Pyramids Wholesale Inc. is recalling Weiner Boner Honey due to undeclared sildenafil and tadalafil. The product was distributed nationwide without FDA approval.

    Product
    Weiner Boner Honey, 12g packet, 100% Organic Formula.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0470-2024·2024-05-01

    ForeverMen Natural Energy Boost Capsules Recalled for Undeclared Sildenafil

    ForeverMen Natural Energy Boost Capsules contain undeclared sildenafil and are marketed without FDA approval, making them an unapproved drug. Consumers should stop using the product immediately.

    Product
    ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0458-2024·2024-05-01

    Sexual Enhancement Product Recalled for Undeclared Prescription Drugs

    Pyramids Wholesale Inc. is recalling HONEY MANUKA BUNNY LOVE nationwide because it contains undeclared sildenafil and/or tadalafil—prescription medications—and was marketed without FDA approval.

    Product
    HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0452-2024·2024-05-01

    Pink Pussycat Honey recalled for undeclared sildenafil and tadalafil content

    Pyramids Wholesale Inc. is recalling Pink Pussycat Honey because it contains undeclared sildenafil and tadalafil and was marketed without FDA approval. The recall affects all lots nationwide.

    Product
    Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0450-2024·2024-05-01

    FDA Recalls Flower Power Female Enhancement for Undeclared Sildenafil and Tadalafil

    Flower Power CBD infused Female Enhancement contains undeclared sildenafil and tadalafil. These prescription drugs were not disclosed to consumers and the product was marketed without FDA approval.

    Product
    Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1613-2024·2024-05-01

    Route 92 Medical delivery catheter recalled due to tip separation risk

    Route 92 Medical is recalling Tenzing 7 delivery catheters because the distal tip may separate from the proximal marker band. The affected units were distributed across the US and New Zealand.

    Product
    Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Devices)·Z-1464-2024·2024-05-01

    VITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk

    Biomerieux Inc is recalling VITEK 2 AST test kits due to ceftriaxone concentration errors that could produce false susceptible results in antimicrobial susceptibility testing.

    Product
    VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0454-2024·2024-05-01

    FDA Recalls libigrow RED DRAGON+ Capsules for Undeclared Sildenafil and Tadalafil

    Pyramids Wholesale Inc. is recalling libigrow RED DRAGON+ capsules nationwide because they contain undeclared sildenafil and tadalafil, prescription medications not approved by the FDA for this product.

    Product
    libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1204-2024·2024-05-01

    Roly Poly Bakery Multigrain Bread Recalled for Undeclared Egg

    Roly Poly Bakery is recalling multigrain bread sold in Connecticut and Massachusetts because it contains undeclared egg, a major food allergen. Consumers with egg allergies should not consume this product.

    Product
    Roly Poly Bakery brand MULTIGRAIN bread; INGREDIENTS: Whole Wheat Flour, High Gluten Flour, Ryechops, Sesame, Caraway, Brownflex, Soybean, Pearl Wheat, Sunflower, Salt, Water.
    Category
    Food
    Distribution
    2 states