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.

876–900 of 1563

  • 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-0442-2021·2021-06-02

    Cardinal Health Recalls Nuedexta Due to Temperature Excursions

    Cardinal Health is recalling 255 bottles of Nuedexta capsules due to intermittent exposure to temperature excursions during storage.

    Product
    NUEDEXTA — NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0460-2021·2021-06-02

    Cardinal Health Recalls Pravachol 40mg Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling Pravachol 40mg tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS
    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 08
    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
  • ModerateFDA (Drugs)·D-0421-2021·2021-06-02

    Cardinal Health Recalls Nitrofurantoin Capsules Due to Storage Temperature Excursions

    Cardinal Health Inc. is recalling 15 bottles of Nitrofurantoin Macrocrystals Capsules 25 mg due to intermittent exposure to temperature excursions during storage.

    Product
    Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.S.A.
    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-0480-2021·2021-06-02

    Cardinal Health Recalls Arnuity Ellipta Due to Temperature Excursions

    Cardinal Health is recalling 353 Arnuity Ellipta inhalers distributed in Florida, Georgia, and South Carolina due to intermittent temperature exposure during storage.

    Product
    ARNUITY ELLIPTA — ARNUITY ELLIPTA (FLUTICASONE FUROATE)
    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-0471-2021·2021-06-02

    Cardinal Health Recalls Ivermectin Tablets Due to Temperature Excursions

    Cardinal Health is recalling 504 cartons of Ivermectin Tablets USP 3 mg due to intermittent exposure to temperature excursions during storage.

    Product
    Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC 4799-806-01 Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 877-381-3336
    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-0499-2021·2021-06-02

    Cardinal Health Recalls Auryxia Tablets Due to Temperature Excursions

    Cardinal Health is recalling 136 bottles of Auryxia (ferric citrate) 210 mg tablets due to intermittent exposure to temperature excursions during storage.

    Product
    AURYXIA — AURYXIA (FERRIC CITRATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0543-2021·2021-06-02

    Cardinal Health Recalls Benzoyl Peroxide Acne Wash Due to Temperature Excursions

    Cardinal Health is recalling 31 bottles of Benzoyl Peroxide 10% Acne Medication Wash due to intermittent temperature exposure during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo Allegan, MI 49010, NDC 45802-318-01
    Category
    Drug
    Distribution
    3 states