Cardinal Health Inc.: Drug Recall

Recall #D-0504-2021 · 03/15/2021

Class II: Risk

Recall Details

Recall Number: D-0504-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Cardinal Health Inc.
Status: Terminated
Date Initiated: 03/15/2021
Location: Dublin, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 357 bottles

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Product Description

Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and Toddlers 50 mL (1 2/3 fl oz) NDC 54838-011-50 Manufactured by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA

Distribution Pattern

FL, GA, SC

Other Recalls by Cardinal Health Inc.

Class II: Risk 08/05/2025

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 II: Risk 07/30/2025

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II: Risk 07/30/2025

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II: Risk 07/30/2025

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II: Risk 04/09/2025

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 extended period of time and inappropriately released.

View all recalls by Cardinal Health Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.