Similac Human Milk Fortifier (Abbott Nutrition) – Potential Seal Defect (2013)
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
Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDITIONAL IRON MAY BE NECESSARY ADD ONLY TO HUMAN MILK - DO NOT ADD WATER NET WT 0.031 OZ (0.90g)***CONTAINS MILK AND SOY INGREDIENTS***USE BY***ABBOTT LABORATORIES"
Brand
Abbott Nutrition
Lot Codes / Batch Numbers
Lot # L31056Z200, List # 54598-934(13) & USE BY 2015FE1
Products Sold
Lot # L31056Z200, List # 54598-934(13) & USE BY 2015FE1; Lot L27385Z200 List # 54598-934(13) USE BY 2014OC1 & Lot L30698Z200 List # 54598 -934(13) USE BY 2015JA1
Abbott Nutrition is recalling Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDITIONAL IRON MAY BE NECE due to Abbott Nutrition (AN) recalled this product from the Canadian market because some of the packets may have an incomplete seal which could allow air to . This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Abbott Nutrition (AN) recalled this product from the Canadian market because some of the packets may have an incomplete seal which could allow air to enter the packet causing food oxidation and/or the powder to leak
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm 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
IN
Page updated: Jan 6, 2026