Abbott Nutrition Recalls Similac Human Milk Fortifier Powder Packets
Abbott Nutrition is recalling Similac Human Milk Fortifier Powder packets in Canada due to incomplete seals that may allow air entry, causing oxidation or powder leakage.
The agency’s classification
FDA (Food): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard involves packaging integrity (incomplete seals) leading to oxidation or leakage rather than a high-risk pathogen or structural defect causing immediate serious injury. No illnesses or injuries are reported in the source text.
Plain-English summary
Abbott Nutrition is recalling Similac Human Milk Fortifier Powder, 0.9 g packets, from the Canadian market. The recall involves specific lots identified as L31056Z200, L27385Z200, and L30698Z200. The product is a powder intended to be added to human milk, and the label indicates it contains milk and soy ingredients.
The recall was initiated because some packets may have an incomplete seal. This defect could allow air to enter the packet, which may cause food oxidation and/or allow the powder to leak. The agency classification for this recall is Class II.
All product in the affected lots was shipped to Canada. Consumers who have this product should check their lot numbers against the list provided by the recalling firm. If the lot number matches, consumers should stop using the product and follow instructions from Abbott Nutrition or the relevant health authority.
The recalled product
- 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"
- Manufacturer
- Abbott Nutrition
- Category
- Food — Infant Nutrition
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # L31056Z200
- List # 54598-934(13) & USE BY 2015FE1
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Abbott Nutrition
See all →- HighSimilac Alimentum infant formula recalled for packaging defect
FDA (Food) · 2022-09-07
- SevereAbbott Nutrition Recalls Vital High Protein Cans Due to Microbial Contamination
FDA (Food) · 2017-02-08
- SevereAbbott Nutrition Recalls Nepro Vanilla Due to Microbial Contamination
FDA (Food) · 2017-02-08
- HighAbbott Nutrition Recalls Promote with Fiber Vanilla Due to Microbial Contamination
FDA (Food) · 2017-02-08
- HighAbbott Nutrition Recalls Oxepa Cans Due to Microbial Contamination
FDA (Food) · 2017-02-08
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- SevereAbbott Similac Human Milk Fortifier Recalled Due to Pathogen Risk
FDA (Food) · 2022-03-16
- HighSimilac Alimentum infant formula recalled for packaging defect
FDA (Food) · 2022-09-07
- ModerateAbbott Recalls Water Bottles Labeled as Similac Pro-Advance Infant Formula
FDA (Food) · 2020-07-22
- HighSimilac Total Comfort infant formula recalled for compromised seal integrity
FDA (Food) · 2022-11-23
- ModerateAbbott Recalls Similac Pro-Sensitive Bottles Due to Packaging Error
FDA (Food) · 2019-09-18
- HighSimilac Special Care infant formula recalled for compromised seal
FDA (Food) · 2022-11-23