The Recall Desk

Hazard

Temperature Excursion recalls

289 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
289
Critical
0
Severe
4
Most recent
2025-09-24

Of the 289 temperature excursion recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (1%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all temperature excursion recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

76–100 of 289

  • HighFDA (Devices)·Z-2101-2021·2021-07-28

    Stryker Cortoss Bone Augmentation Material Recalled for Temperature Storage Violation

    Stryker Spine recalled Cortoss Bone Augmentation Material due to a 12-hour temperature excursion at the distribution center that could have compromised product sterility and efficacy.

    Product
    Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2100-2021·2021-07-28

    Cortoss Bone Augmentation Material Recalled Due to Storage Temperature Excursion

    Stryker Spine is recalling 559 units of Cortoss Bone Augmentation Material 5cc Cartridges due to a 12-hour temperature excursion at the distribution center. The affected lot may not meet required storage conditions.

    Product
    Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1937-2021·2021-06-30

    OneTouch Ultrasoft Lancets recalled due to temperature exposure during shipping

    Cardinal Health is recalling 531 boxes of OneTouch Ultrasoft Lancets shipped February-March 2021 due to temperature exposure during shipment that may cause inaccurate test results.

    Product
    ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0459-2021·2021-06-02

    Cardinal Health Recalls Synjardy Tablets Due to Temperature Excursions

    Cardinal Health is recalling 751 bottles of Synjardy XR tablets distributed in Florida, Georgia, and South Carolina due to intermittent temperature exposure during storage.

    Product
    SYNJARDY — SYNJARDY (EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0522-2021·2021-06-02

    Cardinal Health Recalls Belsomra Tablets Due to Temperature Excursions

    Cardinal Health is recalling 119 cartons of Belsomra (suvorexant) 10 mg tablets due to intermittent temperature excursions during storage.

    Product
    Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets Rx only NDC 00006-0033-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ…
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0585-2021·2021-06-02

    Cardinal Health Recalls Folivane-Plus Capsules Due to Temperature Excursions

    Cardinal Health is recalling 80 bottles of Folivane-Plus capsules because they were intermittently exposed to temperature excursions during storage.

    Product
    Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules 90 Capsules Rx Only NDC 13811-539-90 Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0587-2021·2021-06-02

    Cardinal Health Recalls Restora Omega-3 Supplement Due to Temperature Excursions

    Cardinal Health Inc. is recalling 31 cartons of Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules due to intermittent exposure to temperature excursions during storage.

    Product
    Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement NDC 52747-200-30 Marketed by US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0432-2021·2021-06-02

    Cardinal Health Recalls Gemcitabine Injection Due to Temperature Excursions

    Cardinal Health is recalling Gemcitabine Injection 200mg/5.26ml vials due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0478-2021·2021-06-02

    Cardinal Health Recalls Advair HFA Inhalers Due to Temperature Excursions

    Cardinal Health is recalling 297 units of Advair HFA inhalers due to intermittent temperature exposure during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0573-2021·2021-06-02

    Cardinal Health Recalls Proair HFA Inhalers Due to Temperature Excursions

    Cardinal Health Inc. is recalling 26,895 Proair HFA inhalers due to intermittent exposure to temperature excursions during storage.

    Product
    Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net Contents Rx only NDC 59310-579-22 Mktd by: Teva Respiratory, LLC Horsham, PA 19044 Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0516-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 19 bottles of Vitamin D3 25mcg tablets because they were intermittently exposed to temperature excursions during storage.

    Product
    VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0539-2021·2021-06-02

    Cardinal Health Recalls Zolpidem Tablets Due to Temperature Excursions

    Cardinal Health is recalling 55 boxes of Zolpidem Tartrate Sublingual Tablets 3.5 mg due to intermittent exposure to temperature excursions during storage.

    Product
    ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLET
    Category
    Drug
    Distribution
    3 states