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.

901–925 of 1563

  • 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-0540-2021·2021-06-02

    Cardinal Health Recalls HySept Solution Due to Temperature Excursions

    Cardinal Health is recalling 236 bottles of HySept Solution 0.25% Sodium Hypochlorite due to intermittent temperature excursions during storage.

    Product
    HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076
    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
  • ModerateFDA (Drugs)·D-0411-2021·2021-06-02

    Cardinal Health Recalls COSOPT Eye Drops Due to Temperature Excursions

    Cardinal Health Inc. is recalling 12 bottles of COSOPT ophthalmic solution due to intermittent temperature excursions during storage.

    Product
    COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10ML Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solution Rx only NDC/UPC 174780-605-10 Distributed by: Akorn, Inc. Lake Forest, IL 60
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0493-2021·2021-06-02

    Cardinal Health Recalls Leucovorin Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling Leucovorin 15mg tablets due to intermittent temperature excursions during storage. The affected products were distributed in Florida, Georgia, and South Carolina.

    Product
    LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0467-2021·2021-06-02

    Cardinal Health Recalls Iron 100 Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling Iron 100 with Vitamin C Tablets due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Madison, MS 39110
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0580-2021·2021-06-02

    Cardinal Health Recalls Levalbuterol Inhalers Due to Temperature Excursions

    Cardinal Health is recalling 828 Levalbuterol tartrate HFA inhalers distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.

    Product
    LEVALBUTEROL TARTRATE HFA INHALATION — LEVALBUTEROL TARTRATE HFA INHALATION (LEVALBUTEROL TARTRATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0477-2021·2021-06-02

    Cardinal Health Recalls Flovent Diskus Inhalers Due to Temperature Excursions

    Cardinal Health Inc. is recalling 237 units of Flovent Diskus 100mcg inhalers due to intermittent temperature excursions during storage.

    Product
    FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0571-2021·2021-06-02

    Cardinal Health Recalls Colcrys Tablets Due to Temperature Excursions

    Cardinal Health is recalling 160 bottles of Colcrys tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015,NDC 64764-119-07
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0579-2021·2021-06-02

    Cardinal Health Recalls Balziva Due to Temperature Excursions

    Cardinal Health Inc. is recalling 23 bottles of Balziva (norethindrone and ethinyl estradiol) due to intermittent exposure to temperature excursions during storage.

    Product
    BALZIVA — BALZIVA (NORETHINDRONE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0561-2021·2021-06-02

    Cardinal Health Recalls Budesonide and Formoterol Inhalers for Temperature Excursions

    Cardinal Health Inc. is recalling 905 units of Budesonide and Formoterol Fumarate Dihydrate inhalers due to intermittent temperature exposure during storage.

    Product
    BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0535-2021·2021-06-02

    Cardinal Health Recalls Ciprodex Eye Drops Due to Temperature Excursions

    Cardinal Health is recalling Ciprodex eye drops due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML; NDC/UPC 0078-0799-75; RX; DROPS
    Category
    Drug
    Distribution
    3 states