The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

2051–2075 of 29084

  • SevereFDA (Drugs)·D-0361-2025·2025-04-16

    Chlorpromazine Hydrochloride Tablets Recalled Due to Impurity

    Zydus Pharmaceuticals is recalling chlorpromazine hydrochloride 10 mg tablets due to the presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit. The recall affects 3,144 bottles distributed nationwide.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1543-2025·2025-04-16

    Stimulation RC Clinician Programmer Application Software Communication Issue

    The Stimulation RC Clinician Programmer Application (Model A71400) has a software issue that can permanently disable communication with certain implantable neurostimulators when a specific intraoperative programming sequence is used. Approximately 1,493 devices were distributed worldwide.

    Product
    Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1458-2025·2025-04-16

    Medline Heart Basin Procedure Kits with Aortic Cannula Recalled

    Medline medical procedure kits containing Medtronic Aortic Root Cannula are recalled due to potential excess material in the male luer connectors on the aortic cannula.

    Product
    Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF
    Category
    Medical Device
    Distribution
    9 states
  • SevereNHTSA·25V248000·2025-04-16

    Yamaha motorcycle throttle position sensor fault can stall the engine

    Pure Sports Distributing is recalling certain 2021-2025 Yamaha MT-09, MT-10 and XSR900 motorcycles because throttle position sensor brushes may slide excessively, causing unstable idling or an engine stall.

    Product
    YAMAHA — YAMAHA XSR900, MT-09 SP, MT-10, MT-09
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V247000·2025-04-16

    BMW X3 front brake discs may have been damaged before installation

    BMW is recalling certain 2025 X3 30 xDrive vehicles because the front brake discs may have been damaged during transport before they were installed on the vehicle.

    Product
    BMW — BMW X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2025·2025-04-16

    Haloperidol Decanoate Injection Recalled for Sterility Assurance Failure

    Somerset Therapeutics is recalling Haloperidol Decanoate Injection 50mg/mL vials nationwide due to lack of assurance of sterility from bacterial contamination detected in media fill testing.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1457-2025·2025-04-16

    Medline Medical Procedure Kits with Aortic Root Cannula Recalled

    Medline is recalling medical procedure kits containing a Medtronic Aortic Root Cannula due to potential excess material in the male lures on the cannula. The recall affects 468 units distributed across nine US states.

    Product
    Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0359-2025·2025-04-16

    Proactiv Emergency Blemish Relief recalled for benzene contamination

    Alchemee LLC is recalling Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%) due to the presence of benzene, a chemical contaminant. The recall affects approximately 38,237 bottles distributed nationwide.

    Product
    Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, CA 90401, Made in the USA, UPC 7 35786 01921 1, UPC 8 42944 10223 1, and also packaged as a twin pack UPC 8 42944 10241 5,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1505-2025·2025-04-16

    Medline Medical Convenience Kits Recalled for Defective Endotracheal Tubes

    Medline is recalling multiple medical convenience kits distributed in California that contain defective intubation endotracheal tubes previously recalled by the manufacturer Smiths Medical. The affected kits are used for neonatal and pediatric resuscitation and intubation procedures.

    Product
    Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RESUSCITATION KIT, REF ACC010381C; 5) PEDS GREY-PINK-RED, REF ACC010395; 6
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0357-2025·2025-04-16

    Haloperidol Decanoate Injection Recalled for Sterility Assurance Failure

    Somerset Therapeutics is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility resulting from bacterial contamination detected during media fill testing. The recall affects 23,960 vials distributed nationwide.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0354-2025·2025-04-16

    Methocarbamol Injection USP Recalled Due to Sterility Assurance Concerns

    Somerset Therapeutics is recalling Methocarbamol Injection USP (1,000 mg/10 mL vials) nationwide due to lack of assurance of sterility following bacterial contamination in media fill testing.

    Product
    METHOCARBAMOL — METHOCARBAMOL (METHOCARBAMOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1459-2025·2025-04-16

    Medline Medical Procedure Kits with Medtronic Aortic Cannula Recalled

    Medline medical procedure kits containing a Medtronic Aortic Root Cannula are being recalled due to potential excess material in the male lures on the aortic cannula. The kits were distributed in nine US states.

    Product
    Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0360-2025·2025-04-16

    Proactiv Skin Smoothing Exfoliator recalled for benzene contamination

    Alchemee, LLC is recalling Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%) due to the presence of benzene, a known chemical contaminant.

    Product
    Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 fl. oz. (177.4 mL), UPC 7 35786 01528 2; b) 0.33 OZ (9.45g), UPC 8 42944 10223 1; Distributed by Alchemee, LLC, Santa Monica, CA 90401,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0358-2025·2025-04-16

    Haloperidol Decanoate Injection Recalled Due to Sterility Concerns

    Somerset Therapeutics is recalling Haloperidol Decanoate Injection (100 mg/mL, 1 mL vials) due to lack of assurance of sterility caused by bacterial contamination detected in media fill testing.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0702-2025·2025-04-16

    365 Whole Foods Market Frozen Macaroni and Cheese Recall

    365 Whole Foods Market Small Bites Macaroni & Cheese (8.5 oz) is being recalled because it contains undeclared eggs and pork, which pose a hazard to consumers with allergies.

    Product
    365 Whole Foods Market Small Bites Macaroni & Cheese. Net Wt 8.5 oz (240g) Keep Frozen. UPC 99482499709. Distributed by: Whole Foods Market, Austin, TX
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0355-2025·2025-04-16

    Haloperidol Decanoate Injection Recalled for Sterility Assurance Defect

    Somerset Therapeutics is recalling 997 vials of Haloperidol Decanoate Injection 50mg/mL nationwide due to lack of assurance of sterility following bacterial contamination detected in a media fill validation test.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1512-2025·2025-04-16

    Hippo 072 Aspiration System recalled for distal tip detachment risk

    Qapel Medical Inc. is recalling the Hippo 072 Aspiration System and related components because the aspiration catheter distal tip may detach, potentially causing vessel rupture or vasospasm.

    Product
    Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95
    Category
    Medical Device
    Distribution
    29 states
  • SevereNHTSA·25E027000·2025-04-14

    Nova Bus Recalls ZF Brake Chambers Due to Air Leak Risk

    Nova Bus is recalling specific ZF brake chambers sold as replacement parts for buses because improper manufacturing may cause air leaks, increasing the risk of unexpected braking, overheating, or fire.

    Product
    SERVICE BRAKES, AIR:DISC:CHAMBER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V240000·2025-04-11

    Mercedes-Benz Recalls 2024 E-Class Models for Electrical Fire Risk

    Mercedes-Benz is recalling 2024 E 350 and E 450 vehicles because improperly secured electrical ground connections may overheat and increase the risk of a fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E 350, E 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V236000·2025-04-11

    Ford Recalls 2017-2018 F-150, Expedition, Navigator for Brake Leak

    Ford is recalling 2017-2018 F-150, Expedition, and Lincoln Navigator vehicles because a brake master cylinder defect may cause fluid leaks, reducing braking ability and increasing crash risk.

    Product
    FORD — FORD, LINCOLN EXPEDITION, F-150, NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V238000·2025-04-11

    Ford Recalls 2024-2025 E-Transit Chassis Due to Battery Fire Risk

    Ford is recalling 2024-2025 E-Transit Chassis vehicles because battery tray rails may crack, allowing water entry that could cause a fire.

    Product
    FORD — FORD E-TRANSIT CHASSIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V241000·2025-04-11

    Jayco Recalls 2025-2026 Entegra Motorhomes Due to Fuel Leak Risk

    Jayco is recalling 2025-2026 Entegra Aspire, Anthem, and Cornerstone motorhomes because a fuel filter housing may leak, increasing fire risk.

    Product
    ENTEGRA — ENTEGRA ANTHEM, CORNERSTONE, redundant ASPIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V234000·2025-04-10

    Acura ZDX stabilizer bar bracket bolts may loosen and separate

    Honda is recalling certain 2024 Acura ZDX vehicles because passenger-side front stabilizer bar bracket bolts may loosen and separate from the vehicle frame.

    Product
    ACURA — ACURA ZDX
    Category
    Vehicle
    Distribution
    Distributed nationwide