Cardinal Health Inc. recall records

11 reported ongoing

14 records in this archive. Latest source date Aug 5, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA drug enforcement

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. by: Sandoz Inc., Princeton...

Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL

Class IIReported ongoing

Distribution: KS

Official source for Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further pac...
FDA drug enforcement

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 Nordisk Inc., Plainsboro, NJ ...

Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated st...

Class IIReported ongoing

Distribution: NC, SC, VA

Official source for Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subc...
FDA drug enforcement

LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Card...

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IReported ongoing

Distribution: Nationwide in the USA

Official source for LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydro...
FDA drug enforcement

LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India ND...

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IReported ongoing

Distribution: Nationwide in the USA

Official source for LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle...
FDA drug enforcement

LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in I...

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IReported ongoing

Distribution: Nationwide in the USA

Official source for LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper...
FDA drug enforcement

LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017...

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IReported ongoing

Distribution: Nationwide in the USA

Official source for LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 ...
FDA drug enforcement

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 Cardinal Health, Dublin, Ohio 4301...

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IReported ongoing

Distribution: Nationwide in the USA

Official source for LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (1...
FDA drug enforcement

LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70...

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IReported ongoing

Distribution: Nationwide in the USA

Official source for LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, St...
FDA drug enforcement

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, Box NDC 0002-8799-59, Pen ...

TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.

Class IReported completed

Distribution: NM only

Official source for Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box...

Reasons in these listed records

  • Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
  • CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
  • Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extende...
  • Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

These examples come from this result page and are not a ranking of every recall reason.

Checking Cardinal Health Inc.

Is there a recall on cardinal health inc. right now?

This archive contains 14 records, including 11 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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