The Recall Desk

Archive

November 2025 recalls

538 recalls were announced in November 2025.

What the numbers show

Critical
62
Severe
48
High
306
Moderate
118
Low
4

Of the 538 recalls this month scored against our rubric, 12% are Critical, 9% are Severe.

501–538 of 538

  • ModerateFDA (Devices)·Z-0405-2026·2025-11-05

    Three month all in one bundles recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Initiation 3 Month All in One Bundle because the product lacks 510(k) clearance.

    Product
    Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0393-2026·2025-11-05

    Refill coated and nude regular tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Refill 18 Coated Regular and 18 Nude Regular Tampons because the product lacks 510(k) clearance.

    Product
    Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0406-2026·2025-11-05

    Three month regular flow bundles recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Initiation 3 Month Regular Flow Bundle because the product lacks 510(k) clearance.

    Product
    Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0402-2026·2025-11-05

    Initiation coated and nude regular tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Initiation 18 Coated Regular and 18 Nude Regular Tampons because the product lacks 510(k) clearance.

    Product
    Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0149-2026·2025-11-05

    Lisdexamfetamine 60 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 60 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0138-2026·2025-11-05

    Lipophilic foam base recalled over an unclassified labeling problem

    Letco Medical is recalling 173 500 ml bottles of Espumil lipophilic foam base over a labeling issue recorded as not elsewhere classified.

    Product
    Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0391-2026·2025-11-05

    Refill coated super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Refill 36 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0146-2026·2025-11-05

    Lisdexamfetamine 30 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 30 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0148-2026·2025-11-05

    Lisdexamfetamine 50 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 50 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0147-2026·2025-11-05

    Lisdexamfetamine capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 40 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0390-2026·2025-11-05

    Refill tampon packs recalled because the product lacks 510k clearance

    Daye is recalling 3,074 packs of Refill 36 Coated Regular Tampons because the product lacks 510(k) clearance.

    Product
    Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0394-2026·2025-11-05

    Refill coated and nude super tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Refill 18 Coated Super and 18 Nude Super Tampons because the product lacks 510(k) clearance.

    Product
    Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0392-2026·2025-11-05

    Refill regular and super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Refill 18 Coated Regular and 18 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0383-2026·2025-11-05

    Coated regular and super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Regular and 9 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0139-2026·2025-11-05

    Everolimus tablets recalled after an out of specification impurity result

    Endo USA is recalling 6,655 cartons of Everolimus tablets 5 mg after results came back out of specification for impurity IP-C.

    Product
    Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0142-2026·2025-11-05

    Everolimus 2.5 mg tablets recalled after an out of specification impurity result

    Endo USA is recalling 2,035 cartons of Everolimus tablets 2.5 mg after results came back out of specification for impurity IP-C.

    Product
    Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0395-2026·2025-11-05

    Refill three month trial tampon boxes recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Refill 3 Month Trial Tampon Box because the product lacks 510(k) clearance.

    Product
    Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0327-2026·2025-11-05

    MRI systems recalled over electrode spacing below the required safety standard

    Canon Medical Systems is recalling two Vantage Galan 3T MRI systems because components do not meet the required distance between electrodes for IEC 60601-1 compliance.

    Product
    VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0398-2026·2025-11-05

    Refill three month heavy flow bundles recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Refill 3 Month Heavy Flow Bundle because the product lacks 510(k) clearance.

    Product
    Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0150-2026·2025-11-05

    Lisdexamfetamine 70 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 70 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2026·2025-11-05

    Coated and nude super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Super Tampons and 9 Nude Super Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0401-2026·2025-11-05

    Mixed regular and super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Initiation 18 Coated Regular and 18 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0404-2026·2025-11-05

    Three month trial tampon boxes recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of the Initiation 3 Month Trial Tampon Box because the product lacks 510(k) clearance.

    Product
    Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·036-2025·2025-11-04

    Brazilian Taste Recalls Frozen Chicken and Beef Croquettes for Undeclared Sesame

    Brazilian Taste is recalling approximately 4,120 pounds of frozen chicken and beef croquettes because they contain sesame, an undeclared allergen.

    Product
    Brazilian Taste — Brazilian Taste Recalls Frozen Chicken and Beef Croquette Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·25V760000·2025-11-04

    Western Star and Freightliner trucks recalled for loose axle fasteners

    Daimler Trucks North America is recalling certain 2020–2026 Western Star and Freightliner commercial trucks because axle clamp fasteners may be loose, increasing the risk of loss of vehicle control and crash.

    Product
    FREIGHTLINER — FREIGHTLINER, WESTERN STAR 108SD, 114SD, 122SD, BUSINESS CLASS M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V758000·2025-11-04

    Spartan Fire Fire Trucks Recalled for Door Latch Defect

    Marion Body Works is recalling 2024-2025 Spartan Fire FC-94, Gladiator, and Metrostar vehicles because the cab door latch may fail to open.

    Product
    SPARTAN FIRE — SPARTAN FIRE FC-94, GLADIATOR, METROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V753000·2025-11-03

    Volvo VAH trucks recalled for seat belt anchor defects

    Volvo Trucks is recalling 2019-2026 VAH trucks because the passenger seat belt anchor may fail due to inadequate floor reinforcement, preventing proper occupant restraint in crashes.

    Product
    VOLVO — VOLVO VAH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V754000·2025-11-03

    McNeilus Recalls 2024-2025 Volterra Trucks for Missing Reflectors

    McNeilus is recalling 2024-2025 Volterra ZSL side loader trucks because missing side reflectors may reduce visibility and increase crash risk.

    Product
    MCNEILUS — MCNEILUS VOLTERRA ZSL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V757000·2025-11-03

    2026 Volvo VNL trucks recalled for roof center marker light failure

    Volvo Trucks is recalling certain 2026 VNL commercial trucks because the roof center marker lights may fail to illuminate, reducing visibility and increasing crash risk.

    Product
    VOLVO — VOLVO VNL (4)
    Category
    Vehicle
    Distribution
    Distributed nationwide

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