The Recall Desk

Hazard

Cgmp Deviation recalls

1,563 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,563
Critical
1
Severe
288
Most recent
2026-09-09

Of the 1,563 cgmp deviation recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 288 (18%) 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 cgmp deviation 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.

801–825 of 1563

  • ModerateFDA (Drugs)·D-0441-2021·2021-06-02

    Cardinal Health Recalls Eszopiclone Tablets Due to Temperature Excursions

    Cardinal Health is recalling 29 bottles of Eszopiclone 3mg tablets due to intermittent temperature exposure during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0594-2021·2021-06-02

    Cardinal Health Recalls Corgard Tablets Due to Temperature Excursions

    Cardinal Health is recalling Corgard (nadolol) 40 mg tablets due to intermittent exposure to temperature excursions during storage.

    Product
    Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distributed by US WorldMeds, LLC, Louisville, KY 40241
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0560-2021·2021-06-02

    Cardinal Health Recalls Intrarosa Prasterone Vaginal Inserts Due to Temperature Excursions

    Cardinal Health Inc. is recalling 205 cartons of Intrarosa Prasterone Vaginal Inserts due to intermittent temperature excursions during storage.

    Product
    Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured for: Ednoceutics, Inc. Quebec City, Canada, G1V 4M7 Distributed by: AMAG Pharmaceuticals, Inc. Waltam, MA 02451, NDC 64011-601-28
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0530-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 47 bottles of NAT B VIT D3 2000U tablets due to intermittent exposure to temperature excursions during storage.

    Product
    NAT B VIT D3 2000U 100; NDC/UPC 079854041125; OTC; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0479-2021·2021-06-02

    Cardinal Health Recalls Arnuity Ellipta Inhalers Due to Temperature Excursions

    Cardinal Health Inc. is recalling 513 Arnuity Ellipta inhalers distributed in Florida, Georgia, and South Carolina due to intermittent exposure to temperature excursions during storage.

    Product
    ARNUITY ELLIPTA 100MCG 30INH; NDC/UPC 173087410; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0426-2021·2021-06-02

    Cardinal Health Recalls Enoxaparin Syringes Due to Temperature Excursions

    Cardinal Health is recalling 64 boxes of Enoxaparin Dofium Injection 150mg/1ml syringes due to intermittent temperature excursions during storage.

    Product
    ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGES
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0533-2021·2021-06-02

    Cardinal Health Recalls Tobrex Ointment Due to Temperature Excursions

    Cardinal Health Inc. is recalling 28 tubes of Tobrex 0.3% Ophthalmic Ointment due to intermittent exposure to temperature excursions during storage.

    Product
    TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0558-2021·2021-06-02

    Cardinal Health Recalls Promethazine Oral Solution Due to Temperature Excursions

    Cardinal Health Inc. is recalling Promethazine Plain Oral Solution due to intermittent temperature excursions during storage.

    Product
    PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0544-2021·2021-06-02

    Cardinal Health Recalls Polyethylene Glycol 3350 Powder for Temperature Excursions

    Cardinal Health Inc. is recalling 163 bottles of Polyethylene Glycol 3350 Powder for Solution due to intermittent exposure to temperature excursions during storage.

    Product
    POLYETHYLENE GLYCOL 3350 — POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0434-2021·2021-06-02

    Cardinal Health Recalls Bevespi Aerosphere Due to Temperature Excursions

    Cardinal Health is recalling 355 inhalers of Bevespi Aerosphere due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    BEVESPI AEROSPHERE — BEVESPI AEROSPHERE (GLYCOPYRROLATE AND FORMOTEROL FUMARATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0504-2021·2021-06-02

    Cardinal Health Recalls Ferrous Sulfate Drops Due to Temperature Excursions

    Cardinal Health Inc. is recalling 357 bottles of Ferrous Sulfate Drops for infants and toddlers due to intermittent temperature excursions during storage.

    Product
    Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and Toddlers 50 mL (1 2/3 fl oz) NDC 54838-011-50 Manufactured by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0532-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Supplements Due to Temperature Excursions

    Cardinal Health Inc. is recalling 205 bottles of Vitamin D3 Cholecalciferol 50,000 IU dietary supplements due to intermittent exposure to temperature excursions during storage.

    Product
    Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0444-2021·2021-06-02

    Cardinal Health Recalls Benzefoam Emollient Foam Due to Temperature Excursions

    Cardinal Health Inc. is recalling Benzefoam Emollient Foam due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0431-2021·2021-06-02

    Cardinal Health Recalls Edarbyclor Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 273 bottles of Edarbyclor tablets due to intermittent exposure to temperature excursions during storage.

    Product
    EDARBYCLOR — EDARBYCLOR (AZILSARTAN KAMEDOXOMIL AND CHLORTHALIDONE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0486-2021·2021-06-02

    Cardinal Health Recalls Triumeq Tablets Due to Temperature Excursions

    Cardinal Health is recalling 2,264 bottles of Triumeq tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    TRIUMEQ — TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0531-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Supplements Due to Temperature Excursions

    Cardinal Health Inc. is recalling 523 bottles of Vitamin D3 Cholecalciferol 50,000 IU dietary supplements due to intermittent exposure to temperature excursions during storage.

    Product
    Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0451-2021·2021-06-02

    Cardinal Health Recalls NURTEC ODT Due to Temperature Excursions

    Cardinal Health is recalling NURTEC ODT (rimegepant) tablets due to intermittent exposure to temperature excursions during storage.

    Product
    NURTEC ODT — NURTEC ODT (RIMEGEPANT SULFATE)
    Category
    Drug
    Distribution
    3 states