Cardinal Health recalls

Cardinal Health has 316 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 3 Sep 2025. 54 are still ongoing. The most frequent reason is manufacturing (cgmp) deviations.

Total recalls316since 2013

Last 12 months0reported

Class I103% of total

Ongoing54latest 3 Sep 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 1May 0 0 3Aug 1 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 10 3%Class II 304 96%Class III 2 1%

Why cardinal health is recalled

Product types

Brands

By year

202552%
202362%
202293%
202122772%
20205116%
201921%
201631%
201531%
2013103%

Ongoing cardinal health recalls

54 active

Reported	Class	Recall	Company	Reason	Where
3 Sep 2025Drug	CLASS II	Enoxaparin Sodium Injection, USP, 30 mg recalled by Cardinal HealthEnoxaparin Sodium	Cardinal Health	Packaging Defects	KS
13 Aug 2025Drug	CLASS II	Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector recalledXolair	Cardinal Health	Manufacturing (CGMP) Deviations	Nationwide
13 Aug 2025Drug	CLASS II	Xolair (omalizumab injection), 75 mg recalled by Cardinal HealthXolair	Cardinal Health	Manufacturing (CGMP) Deviations	Nationwide
13 Aug 2025Drug	CLASS II	Recombinate, [Antihemophilic Factor (Recombinant)] vials recalled	Cardinal Health	Manufacturing (CGMP) Deviations	Nationwide
7 May 2025Drug	CLASS II	Wegovy (semaglutide) injection recalled by Cardinal Health	Cardinal Health	Temperature Abuse	NC, SC, VA
29 Nov 2023Drug	CLASS I	Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) recalledLubricant Drops	Cardinal Health	Sterility	Nationwide

All cardinal health recalls, newest first

316 total

Reported	Class	Recall	Company	Reason	Where
3 Sep 2025Drug	CLASS II	Enoxaparin Sodium Injection, USP, 30 mg recalled by Cardinal HealthEnoxaparin Sodium	Cardinal Health	Packaging Defects	KS
13 Aug 2025Drug	CLASS II	Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector recalledXolair	Cardinal Health	Manufacturing (CGMP) Deviations	Nationwide
13 Aug 2025Drug	CLASS II	Xolair (omalizumab injection), 75 mg recalled by Cardinal HealthXolair	Cardinal Health	Manufacturing (CGMP) Deviations	Nationwide
13 Aug 2025Drug	CLASS II	Recombinate, [Antihemophilic Factor (Recombinant)] vials recalled	Cardinal Health	Manufacturing (CGMP) Deviations	Nationwide
7 May 2025Drug	CLASS II	Wegovy (semaglutide) injection recalled by Cardinal Health	Cardinal Health	Temperature Abuse	NC, SC, VA
29 Nov 2023Drug	CLASS I	Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) recalledLubricant Drops	Cardinal Health	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Leader Lubricant Eye Drops (Propylene Glycol, 0.6%) recalled	Cardinal Health	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Leader Dry Eye Relief (Carboxymethylcellulose Sodium, 1%) recalledDry Eye Relief	Cardinal Health	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) recalledLubricant Drops	Cardinal Health	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Leader Eye Irritation Relief (Polyvinyl alcohol recalledEyes Irritation Relief	Cardinal Health	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Leader Dry Eye Relief (Polyethylene Glycol recalled by Cardinal HealthDry Eye Relief	Cardinal Health	Sterility	Nationwide
14 Dec 2022Device	CLASS II	Dover Closed Urethral Tray with Hydrogel Coated Red Rubber recalled	Cardinal Health	Foreign Material	Nationwide
14 Dec 2022Device	CLASS II	Dover Closed Urethral Tray with Vinyl Catheter/Ch Catheter recalled	Cardinal Health	Other	Nationwide
14 Dec 2022Device	CLASS II	Dover Closed Urethral Tray with Vinyl Catheter Product recalled	Cardinal Health	Other	Nationwide
14 Dec 2022Device	CLASS II	Dover Closed Urethral Tray with Vinyl Catheter/Ch Catheter recalled	Cardinal Health	Other	Nationwide
14 Dec 2022Device	CLASS II	Dover Closed Urethral Tray with Hydrogel Coated Red Rubber recalled	Cardinal Health	Foreign Material	Nationwide
14 Dec 2022Device	CLASS II	Dover Closed Urethral Tray with Vinyl Catheter/Ch Catheter Product recalled	Cardinal Health	Other	Nationwide
25 May 2022Drug	CLASS II	Trulicity (dulaglutide) injection, 1.5 mg/ once weekly-Dose Pens recalled	Cardinal Health	Temperature Abuse	NM
25 May 2022Drug	CLASS I	Humalog KwikPen, Insulin lispro injection, U-100 per mL recalledHumalog	Cardinal Health	Temperature Abuse	NM
25 May 2022Drug	CLASS II	Trulicity (dulaglutide) injection, 0.75 mg/ once weekly-Dose Pens recalledTrulicity	Cardinal Health	Temperature Abuse	NM
22 Dec 2021Device	CLASS II	RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long recalled	Cardinal Health	Sterility	Nationwide
22 Dec 2021Device	CLASS II	Poly-Reinforced Surgical Gowns X-large recalled by Cardinal Health	Cardinal Health	Sterility	Nationwide
22 Dec 2021Device	CLASS II	SmartGown Breathable Surgical Gowns recalled by Cardinal Health	Cardinal Health	Sterility	Nationwide
22 Dec 2021Device	CLASS II	Poly-Reinforced Surgical Gowns XX-large recalled by Cardinal Health	Cardinal Health	Sterility	Nationwide
22 Dec 2021Device	CLASS II	RoyalSilk Non-Reinforced Surgical Gowns XX-large recalled	Cardinal Health	Sterility	Nationwide
22 Dec 2021Device	CLASS II	SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large recalled	Cardinal Health	Sterility	Nationwide
22 Dec 2021Device	CLASS II	Poly-Reinforced Surgical Gowns Large recalled by Cardinal Health	Cardinal Health	Sterility	Nationwide
22 Dec 2021Device	CLASS II	SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large recalled	Cardinal Health	Sterility	Nationwide
22 Dec 2021Device	CLASS II	SmartSleeve Poly-Reinforced Breathable Sleeve Surgical recalled	Cardinal Health	Sterility	Nationwide
22 Dec 2021Device	CLASS II	RoyalSilk Non-Reinforced Surgical Gowns Large recalled	Cardinal Health	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.