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.

851–875 of 1563

  • 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-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-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-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-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…
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0519-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Tablets Due to Temperature Excursions

    Cardinal Health is recalling Vitamin D3 50mcg tablets due to intermittent exposure to temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0564-2021·2021-06-02

    Cardinal Health Recalls Cefazolin Injection Due to Temperature Excursions

    Cardinal Health Inc. is recalling Cefazolin for Injection due to intermittent exposure to temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    CEFAZOLIN — CEFAZOLIN (CEFAZOLIN)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0469-2021·2021-06-02

    Cardinal Health Recalls Pregabalin Capsules Due to Temperature Excursions

    Cardinal Health Inc. is recalling Pregabalin 300mg capsules due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    PREGABALIN — PREGABALIN (PREGABALIN)
    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-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-0458-2021·2021-06-02

    Cardinal Health Recalls Synjardy Tablets Due to Temperature Excursions

    Cardinal Health is recalling 269 bottles of Synjardy XR tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    SYNJARDY — SYNJARDY (EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE)
    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-0420-2021·2021-06-02

    Cardinal Health Recalls Vraylar Capsules Due to Temperature Excursions

    Cardinal Health is recalling 759 bottles of Vraylar (cariprazine) capsules due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
    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