Ferrous Sulfate Drops (Cardinal Health) – Temperature Storage Issue (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Cardinal Health Inc.
Lot Codes / Batch Numbers
All Lots distributed 02/23/2021 through 03/10/2021.
Products Sold
All Lots distributed 02/23/2021 through 03/10/2021.
Cardinal Health Inc. is recalling Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement D due to CGMP Deviations: Intermittent exposure to temperature excursion during storage.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, GA, SC
Page updated: Jan 7, 2026