PlainRecalls

Cardinal Health Inc.

Compiled from official public sources by the editorial team.

240 recalls on record · Latest: Sep 3, 2025

Cardinal Health Inc. Recall Insight

Cardinal Health Inc. appears on 240 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.236% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Sep 3, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 7 critical, 43 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 5 distinct product categories, with issuing agencies dominated by FDA Drug (36), FDA Devices (14). The date window on this page runs from Jun 2, 2021 to Sep 3, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Drug Moderate Sep 3, 2025

Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist…

FDA Drug Moderate Aug 13, 2025

RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01

FDA Drug Moderate Aug 13, 2025

Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55

FDA Drug Moderate Aug 13, 2025

Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.

FDA Drug Moderate May 7, 2025

Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo N…

FDA Drug Critical Nov 29, 2023

LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardin…

FDA Drug Critical Nov 29, 2023

LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, …

FDA Drug Critical Nov 29, 2023

LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardina…

FDA Drug Critical Nov 29, 2023

LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, O…

FDA Drug Critical Nov 29, 2023

LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio…

FDA Drug Critical Nov 29, 2023

LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, D…

FDA Drug Moderate May 25, 2022

Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1…

FDA Drug Critical May 25, 2022

Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis, IN 46285…

FDA Drug Moderate May 25, 2022

Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 00002-14…

FDA Devices Moderate Jun 30, 2021

OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326

FDA Devices Moderate Jun 30, 2021

ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862

FDA Devices Moderate Jun 30, 2021

FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877

FDA Devices Moderate Jun 30, 2021

FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084

FDA Devices Moderate Jun 30, 2021

DEXCOM G6 SENSOR 3 PACK Item Number: 5447552

FDA Devices Moderate Jun 30, 2021

ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174

FDA Devices Moderate Jun 30, 2021

VAPORIZER VICKS 1.5GAL Item Number: 2354942

FDA Devices Moderate Jun 30, 2021

ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610

FDA Devices Moderate Jun 30, 2021

BD UF PEN 32GX4MM 100 NANO Item Number: 4292272

FDA Devices Moderate Jun 30, 2021

ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443

FDA Devices Moderate Jun 30, 2021

AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033

FDA Devices Moderate Jun 30, 2021

FREESTYLE LANCETS 28G 100CT Item Number:2975670

FDA Devices Moderate Jun 30, 2021

ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628

FDA Devices Moderate Jun 30, 2021

ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788

FDA Drug Moderate Jun 2, 2021

Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328

FDA Drug Moderate Jun 2, 2021

xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharm…

FDA Drug Moderate Jun 2, 2021

Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDeli…

FDA Drug Moderate Jun 2, 2021

Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 109…

FDA Drug Moderate Jun 2, 2021

NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS

FDA Drug Moderate Jun 2, 2021

NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL)

FDA Drug Moderate Jun 2, 2021

EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS

FDA Drug Moderate Jun 2, 2021

Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Mad…

FDA Drug Moderate Jun 2, 2021

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 P…

FDA Drug Moderate Jun 2, 2021

ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS

FDA Drug Moderate Jun 2, 2021

Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt Rx Only NDC 0037-6822-10 Distributed by: Meda Ph…

FDA Drug Moderate Jun 2, 2021

Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45 Manufactured for Allegan, Inc. …

FDA Drug Moderate Jun 2, 2021

MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM

FDA Drug Moderate Jun 2, 2021

Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36

FDA Drug Moderate Jun 2, 2021

PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16

FDA Drug Moderate Jun 2, 2021

Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets Rx Only NDC 49702-231-13 Manufactured for: Viiv Healthcare Re…

FDA Drug Moderate Jun 2, 2021

medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-4538-02

FDA Drug Moderate Jun 2, 2021

CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES

FDA Drug Moderate Jun 2, 2021

ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS

FDA Drug Moderate Jun 2, 2021

UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS

FDA Drug Moderate Jun 2, 2021

Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured for: Ednoceutics, Inc. Quebec City, Canada, G1V 4M7 Distribut…

FDA Drug Moderate Jun 2, 2021

Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefilled Syringe Rx only NDC 59762-4538-2 Distributed by: Greenstone, LLC.…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Cardinal Health Inc. with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.