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
289
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 289 (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-0435-2021·2021-06-02

    Cardinal Health Recalls XIGDUO Tablets Due to Temperature Excursions

    Cardinal Health is recalling 664 bottles of XIGDUO tablets because of intermittent temperature exposure during storage. The affected products were distributed in Florida, Georgia, and South Carolina.

    Product
    XIGDUO — XIGDUO (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0569-2021·2021-06-02

    Cardinal Health Recalls COREG CR Capsules Due to Temperature Excursions

    Cardinal Health is recalling 133 bottles of COREG CR 80 mg capsules due to intermittent temperature exposure during storage.

    Product
    COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0418-2021·2021-06-02

    Cardinal Health Recalls Namzaric Due to Temperature Excursions

    Cardinal Health is recalling 659 bottles of Namzaric capsules due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    NAMZARIC — NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0557-2021·2021-06-02

    Cardinal Health Recalls LEVOXYL Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 13 bottles of LEVOXYL tablets due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0456-2021·2021-06-02

    Cardinal Health Recalls Synjardy Tablets Due to Temperature Excursions

    Cardinal Health is recalling 284 bottles of Synjardy tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0428-2021·2021-06-02

    Cardinal Health Recalls Timolol Maleate Ophthalmic Solution Due to Temperature Excursions

    Cardinal Health Inc. is recalling 31 droptainers of Timolol Maleate Ophthalmic Solution 0.5% due to intermittent exposure to temperature excursions during storage.

    Product
    Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Application In The Eye Rx Only NDC 60505-1005-4 Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0455-2021·2021-06-02

    Cardinal Health Recalls Glyxambi Tablets Due to Temperature Excursions

    Cardinal Health is recalling 592 bottles of Glyxambi tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    GLYXAMBI — GLYXAMBI (EMPAGLIFLOZIN AND LINAGLIPTIN)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0546-2021·2021-06-02

    Cardinal Health Recalls Fexofenadine Tablets Due to Temperature Excursions

    Cardinal Health is recalling 321 bottles of Fexofenadine Hydrochloride 180 mg tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Each NDC 45802-571-78 Distributed By Perrigo Allegan, MI 49010
    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-0481-2021·2021-06-02

    Cardinal Health Recalls Trelegy Ellipta Due to Temperature Excursions

    Cardinal Health Inc. is recalling 4,065 cartons of Trelegy Ellipta inhalers due to intermittent exposure to temperature excursions during storage.

    Product
    TRELEGY ELLIPTA — TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0470-2021·2021-06-02

    Cardinal Health Recalls Phenobarbital Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling Phenobarbital Tablets, USP 32.4 mg due to intermittent exposure to temperature excursions during storage.

    Product
    Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, FL 33432
    Category
    Drug
    Distribution
    3 states