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.

776–800 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-0410-2021·2021-06-02

    Cardinal Health Recalls Atropine Sulfate Ophthalmic Solution Due to Temperature Excursions

    Cardinal Health Inc. is recalling 424 bottles of Atropine Sulfate Ophthalmic Solution 1% due to intermittent temperature excursions during storage.

    Product
    Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5 mL Rx only NDC 17478-215-05 Manufactured by: Akorn, Inc.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0505-2021·2021-06-02

    Cardinal Health Recalls Siladryl Liquid Due to Temperature Excursions

    Cardinal Health is recalling 78 bottles of Siladryl 12.5/5ml liquid because of intermittent temperature excursions during storage.

    Product
    SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0559-2021·2021-06-02

    Nature's Truth Calcium Plus D3 Softgels Recalled for Temperature Excursions

    Cardinal Health is recalling Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU softgels due to intermittent temperature excursions during storage.

    Product
    Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels Dietary Supplements Carefully Designed and Distributed by Nature's Truth LLC. Ronkonkoma, NY 11779, UPC 840093100672
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0462-2021·2021-06-02

    Cardinal Health Recalls Sodium Sulfacetamide and Sulfur Cleanser Due to Temperature Excursions

    Cardinal Health Inc. is recalling 16 tubes of Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser due to intermittent temperature excursions during storage.

    Product
    Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) Net Wt. 10 oz. (285 g) Rx Only NDC 50096-502-10 Manufactured for: Rosemar Labs, LLC 2100 West Loop South Suite 900 Houston, TX 77027
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0416-2021·2021-06-02

    Cardinal Health Recalls Restasis Eye Drops Due to Temperature Excursions

    Cardinal Health Inc. is recalling 3,688 bottles of Restasis 0.05% eye drops due to intermittent exposure to temperature excursions during storage.

    Product
    RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RX
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0555-2021·2021-06-02

    Cardinal Health Recalls Chantix Tablets Due to Temperature Excursions

    Cardinal Health is recalling 848 bottles of Chantix (varenicline tartrate) tablets due to intermittent exposure to temperature excursions during storage.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0474-2021·2021-06-02

    Cardinal Health Recalls Brompheniramine and Pseudoephedrine Syrup Due to Temperature Excursions

    Cardinal Health Inc. is recalling 73 cartons of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup due to intermittent temperature excursions during storage.

    Product
    BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, — BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE,)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0515-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 53 bottles of Vitamin D3 25mcg tablets due to intermittent exposure to temperature excursions during storage.

    Product
    VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0525-2021·2021-06-02

    Cardinal Health Recalls Asmanex Twistero Inhalers Due to Temperature Excursions

    Cardinal Health is recalling 122 Asmanex Twistero inhalers distributed in Florida, Georgia, and South Carolina due to intermittent temperature exposure during storage.

    Product
    ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0589-2021·2021-06-02

    Cardinal Health Recalls VIMPAT Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 796 bottles of VIMPAT (lacosamide) 100 mg tablets due to intermittent temperature excursions during storage.

    Product
    VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle; Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0482-2021·2021-06-02

    Cardinal Health Recalls Trelegy Ellipta Inhalers Due to Temperature Excursions

    Cardinal Health is recalling 903 Trelegy Ellipta inhalers distributed in Florida, Georgia, and South Carolina 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-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