Recall archive
12 recalls · page 1 of 1
Reported 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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
FDA (openFDA drug enforcement)
Reported Aug 13, 2025
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported May 7, 2025
Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand · Reason for recall — Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error…
FDA (openFDA drug enforcement)
Reported Nov 29, 2023
LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health Inc.
Matched: Brand · Product details — Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
5 more products in this recall
FDA (openFDA drug enforcement)
Reported May 25, 2022
Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health Inc.
Matched: Brand — TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 30, 2021
FREESTYLE LANCETS 28G 100CT Item Number:2975670
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which…
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 2, 2021
THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
197 more products in this recall
FDA (openFDA drug enforcement)
Reported Apr 7, 2021
Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Cardinal Health Inc.
Matched: Brand — Temperature Abuse
FDA (openFDA drug enforcement)
Reported Jun 3, 2020
Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — The feeding spike sets may leak at the interface of the tube and spike connector.
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 27, 2020
B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2020
S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 16, 2019
Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
FDA (openFDA device enforcement)
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