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.

851–875 of 1563

  • ModerateFDA (Drugs)·D-0461-2021·2021-06-02

    Cardinal Health Recalls Valsartan Tablets Due to Temperature Excursions

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

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0487-2021·2021-06-02

    Cardinal Health Recalls Hydrocortisone Ointment Due to Temperature Excursions

    Cardinal Health Inc. is recalling 23 tubes of Hydrocortisone Ointment USP 1% due to intermittent exposure to temperature excursions during storage.

    Product
    Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-0345-56 Manufactured by: Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28902
    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-0585-2021·2021-06-02

    Cardinal Health Recalls Folivane-Plus Capsules Due to Temperature Excursions

    Cardinal Health is recalling 80 bottles of Folivane-Plus capsules because they were intermittently exposed to temperature excursions during storage.

    Product
    Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules 90 Capsules Rx Only NDC 13811-539-90 Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872
    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-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-0409-2021·2021-06-02

    Cardinal Health Recalls Lidocaine HCL Visc 2% Due to Temperature Excursions

    Cardinal Health Inc. is recalling 240 bottles of Lidocaine HCL Visc 2% 100ml due to intermittent temperature excursions during storage.

    Product
    LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0496-2021·2021-06-02

    Cardinal Health Recalls Enbrace HR Prenatal Vitamins Due to Temperature Excursions

    Cardinal Health is recalling 11 bottles of Enbrace HR prenatal vitamins due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    ENBRACE HR — ENBRACE HR (LEVOMEFOLATE MAGNESIUM, LEUCOVORIN, FOLIC ACID, FERROUS CYSTEINE GLYCINATE, MAGNESIUM ASCORBATE, ZINC ASCORBATE, COCARBOXYLASE, FLAVIN ADENINE DINUCLEOTIDE, NADH, PYRIDOXAL PHOSPHATE ANHYDROUS, COBAMAMIDE, BETAINE, MAGNESIUM L-THREONATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, AND PHOSPHATIDYL SERINE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0432-2021·2021-06-02

    Cardinal Health Recalls Gemcitabine Injection Due to Temperature Excursions

    Cardinal Health is recalling Gemcitabine Injection 200mg/5.26ml vials due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0563-2021·2021-06-02

    Cardinal Health Recalls Medroxyprogesterone Acetate Injectable Due to Temperature Excursions

    Cardinal Health Inc. is recalling 148 syringes of medroxyprogesterone acetate injectable suspension due to intermittent exposure to temperature excursions during storage.

    Product
    medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-4538-02
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0562-2021·2021-06-02

    Cardinal Health Recalls Medroxyprogesterone Acetate Syringes Due to Temperature Excursions

    Cardinal Health is recalling 286 prefilled syringes of medroxyprogesterone acetate due to intermittent temperature excursions during storage.

    Product
    Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefilled Syringe Rx only NDC 59762-4538-2 Distributed by: Greenstone, LLC. Peapack, NJ 07977
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0596-2021·2021-06-02

    Cardinal Health Recalls Cough Syrup Due to Temperature Excursions

    Cardinal Health Inc. is recalling 15 bottles of a cough syrup due to intermittent temperature excursions during storage.

    Product
    Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1 Pint (473 mL) Bulk Container-Not for Household Use Rx Only NDC 60432-275-16 Distributed By: Wockhardt USA, LLC Parsippany, NJ 07054
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0445-2021·2021-06-02

    Cardinal Health Recalls MURO-128 Eye Drops Due to Temperature Excursions

    Cardinal Health is recalling MURO-128 2% eye drops due to intermittent temperature excursions during storage. The affected units were distributed in Florida, Georgia, and South Carolina.

    Product
    MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0500-2021·2021-06-02

    Cardinal Health Recalls Livalo Tablets Due to Temperature Excursions

    Cardinal Health is recalling 453 bottles of Livalo (pitavastatin calcium) 2 mg tablets due to intermittent exposure to temperature excursions during storage.

    Product
    LIVALO — LIVALO (PITAVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0405-2021·2021-06-02

    Cardinal Health Recalls Synthroid Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 123 bottles of Synthroid (levothyroxine sodium) tablets distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.

    Product
    Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0517-2021·2021-06-02

    Cardinal Health Recalls Dibucaine Topical Anesthetic Due to Temperature Excursions

    Cardinal Health Inc. is recalling 701 cartons of Dibucaine Topical Anesthetic 1% Hemorrhoidal Ointment due to intermittent temperature excursions during storage.

    Product
    DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL — DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL (DIBUCAINE)
    Category
    Drug
    Distribution
    3 states