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.

1–25 of 289

  • ModerateFDA (Drugs)·D-0571-2025·2025-08-13

    Xolair auto-injectors exposed to temperatures outside labeled storage requirements

    Xolair (omalizumab injection) 150 mg/mL auto-injectors are being recalled because of CGMP deviations: the product was exposed to temperatures outside its labeled storage requirements. 6 units affected.

    Product
    XOLAIR — XOLAIR (OMALIZUMAB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0573-2025·2025-08-13

    Recombinate antihemophilic factor vials exposed to temperatures outside labeled storage

    Recombinate [Antihemophilic Factor (Recombinant)] 5 mL vials are being recalled because of CGMP deviations: the product was exposed to temperatures outside its labeled storage requirements. 3 units affected.

    Product
    RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1849-2025·2025-06-04

    Abbott Diagnostics Architect Total T36X4ML Calibrator Cold Chain Excursion

    Abbott Diagnostics Architect Total T36X4ML Calibrator units experienced transit delays during severe thunderstorms that may have caused storage outside recommended temperature conditions, potentially resulting in incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1843-2025·2025-06-04

    Abbott Diagnostics ARC Anti-TPO Assay Reagent Affected by Transit Delays

    Abbott Diagnostics ARC Anti-TPO Assay 100TST B Reagent is being recalled because transit delays due to severe thunderstorms may have caused products to be stored outside recommended temperature conditions, increasing the risk of incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1836-2025·2025-06-04

    Ortho Clinical Diagnostics Anti-B Bioclone diagnostic reagent recalled

    Ortho Clinical Diagnostics Anti-B Bioclone reagent is recalled due to cold-chain failures during transit caused by severe thunderstorms. Products may have been stored outside recommended conditions, potentially increasing the risk of incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0116-2025·2024-12-18

    Injectable drug recalled for temperature excursion during storage

    Mckesson Medical-Surgical Inc. is recalling HYLENEX RECOMBINANT (hyaluronidase) injection due to cGMP deviations involving a temperature excursion during storage, which may have compromised drug potency.

    Product
    HYLENEX RECOMBINANT — HYLENEX RECOMBINANT (HYALURONIDASE)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1312-2024·2024-03-27

    Pregnancy Test Control Set Recalled for Temperature Excursion Risk

    McKesson recalls Abbott Rapid Dx pregnancy test control sets due to a refrigerator temperature excursion that could cause inaccurate or delayed test results.

    Product
    Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2024·2024-03-27

    Abbott Point of Care Control Device Recalled Due to Temperature Storage Failure

    Abbott's i-STAT Level 1 control device is recalled because a refrigerator temperature excursion on January 8, 2024, could cause incorrect or delayed test results. The walk-in storage unit failed, causing temperatures to fall below the required range of 35.6-46.4°F.

    Product
    Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1311-2024·2024-03-27

    Sekisui OSOM BVBLUE Bacterial Vaginosis Control Kit recalled due to temperature exposure

    A Sekisui Diagnostics control kit for bacterial vaginosis testing was recalled after exposure to temperatures below the validated storage range for up to 60 minutes due to refrigerator mechanical failure.

    Product
    Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1315-2024·2024-03-27

    Laboratory Control Material Recalled Due to Temperature Storage Excursion

    Abbott Point of Care Control i-STAT Level 3 control material (Lot 121164) is being recalled due to temperature excursions in storage that could affect test accuracy. Affected units were distributed in Arizona, Pennsylvania, and Texas.

    Product
    Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0340-2024·2024-02-28

    Prescription injection drug recalled due to temperature excursion during shipment

    Acthar Gel (repository corticotropin injection) is being recalled due to a temperature excursion during shipping from the manufacturer to distributor. Lot #1564-103 should not be dispensed to patients.

    Product
    ACTHAR — ACTHAR (REPOSITORY CORTICOTROPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0188-2024·2024-01-03

    FDA Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Temperature Storage Deviations

    Cardinal Healthcare is recalling Lisinopril and Hydrochlorothiazide Tablets (10mg/12.5mg) manufactured by Lupin Limited because products were exposed to temperatures outside the labeled storage conditions. Affected batches are Q101699 and Q101981 distributed nationwide.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0189-2024·2024-01-03

    Lithium Carbonate Extended-Release Tablets Recalled for Temperature Excursion

    Cardinal Healthcare recalled Lithium Carbonate Extended-Release Tablets (300 mg, Batch 3138326) distributed nationwide because the products were exposed to temperatures outside their labeled storage conditions during manufacturing.

    Product
    Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0171-2024·2024-01-03

    Bumetanide Tablets Recalled for Exposure to Improper Storage Temperatures

    Bumetanide tablets manufactured by Amneal Pharmaceuticals are being recalled because they were exposed to temperatures outside their labeled storage conditions. The recall affects batch AM211171 distributed nationwide.

    Product
    Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0180-2024·2024-01-03

    Estradiol 0.5mg Tablets Recalled Nationwide for Storage Temperature Deviation

    Cardinal Healthcare is recalling Estradiol 0.5mg tablets (Batch 100023687) nationwide due to exposure to temperatures outside labeled storage specifications. Temperature exposure may affect medication stability.

    Product
    ESTRADIOL — ESTRADIOL (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0172-2024·2024-01-03

    Chlorthalidone Tablets Recalled for Temperature Storage Deviations

    Cardinal Healthcare is recalling Chlorthalidone Tablets, 25mg (Batch 2107329UM) distributed nationwide because products were exposed to temperatures outside the labeled storage conditions.

    Product
    CHLORTHALIDONE — CHLORTHALIDONE (CHLORTHALIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0168-2024·2024-01-03

    Prescription thyroid drug recalled due to temperature storage deviation

    ARMOUR THYROID 120 mg tablets in batch W05543 are being recalled nationwide due to exposure to temperatures outside the labeled storage conditions. No illnesses or injuries have been reported.

    Product
    ARMOUR THYROID — ARMOUR THYROID (THYROID, PORCINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0178-2024·2024-01-03

    Doxycycline Capsules Recalled Due to Temperature Storage Deviation

    Cardinal Healthcare is recalling Doxycycline 100 mg Capsules nationwide due to exposure to temperatures outside labeled storage conditions. No illnesses have been reported.

    Product
    DOXYCYCLINE — DOXYCYCLINE (DOXYCYCLINE)
    Category
    Drug
    Distribution
    Distributed nationwide