Abbott is recalling certain powdered infant formula products from the marketplace in Canada because of possible Cronobacter sakazakii and Salmonella contamination.
This recall was triggered by a recall initiated in the U.S.
Abbott is recalling these products after four consumer complaints in the U.S. related to Cronobacter sakazakii or Salmonella Newport infections in infants who had consumed powder infant formula manufactured in this facility.
The U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and prevention are investigating these four consumer complaints of infant illness related to the infant formula products from Abbott Nutrition’s Sturgis, MI, facility.
The U.S. FDA has initiated an onsite inspection at the facility. Findings to date include several positive Cronobacter results from environmental samples taken by FDA, and adverse inspectional observations by FDA investigators. A review of the firm’s internal records also indicate environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter.
As of the last update, four infant illnesses have been reported. Three are cronobacter infections and one is a Salmonella infection. One death has been reported. Infants became ill between Sept. 6, 2021, and Dec. 2021. Sick people reside in Minnesota, Ohio, and Texas.
Recalled products:
| Brand | Product | Size | UPC | Codes |
| Abbott | Similac Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder | 658 g | 0 55325 00076 1 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder | 964 g | 0 55325 00163 8 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Advance Step 2 Milk-Based Iron-Fortified and Calcium-Enriched Infant Formula Powder | 658 g | 0 55325 00077 8 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Advance Step 2 Milk-Based Iron-Fortified and Calcium-Enriched Infant Formula Powder | 964 g | 0 55325 00164 5 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Alimentum Step 1 Hypoallergenic Infant Formula Powder | 400 g | 0 55325 00061 7 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Human Milk Fortifier Powder | 50 x 0.90 g | 0 55325 54598 9 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Pro-Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder | 227 g | 0 55325 00260 4 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Pro-Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder | 584 g | 0 55325 00281 9 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Pro-Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder | 658 g | 0 55325 00249 9 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Pro-Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder | 859 g | 0 55325 00283 3 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Brand | Product | Size | UPC | Codes |
| Abbott | Similac Pro-Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder | 964 g | 0 55325 00254 3 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Pro-Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder | 1134 g | 0 55325 00306 9 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Pro-Advance Step 2 Milk-Based Iron-Fortified and Calcium-Enriched Infant Formula Powder | 584 g | 0 55325 00286 4 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Pro-Advance Step 2 Milk-Based Iron-Fortified and Calcium-Enriched Infant Formula Powder | 658 g | 0 55325 00256 7 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Pro-Advance Step 2 Milk-Based Iron-Fortified and Calcium-Enriched Infant Formula Powder | 859 g | 0 55325 00288 8 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Pro-Advance Step 2 Milk-Based Iron-Fortified and Calcium-Enriched Infant Formula Powder | 964 g | 0 55325 00258 1 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Sensitive (Lactose Sensitivity) Step 1 Milk-Based Iron-Fortified Infant Formula Powder | 638 g | 0 55325 00121 8 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Total Comfort Step 1 Milk-Based Iron-Fortified Infant Formula Powder | 227 g | 0 55325 62662 6 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Total Comfort Step 1 Milk-Based Iron-Fortified Infant Formula Powder | 638 g | 0 55325 62660 2 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
| Abbott | Similac Total Comfort Step 1 Milk-Based Iron-Fortified Infant Formula Powder | 964 g | 0 55325 00165 2 | All lot codes where: – The first 2 digits range from 22 through to 37; AND – Contain K8, SH, or Z2; AND – Have an expiration date of 1APR2022 or after |
Consumers and food businesses should check to see if they have the recalled products in their homes or establishments. Recalled products should be thrown out or returned to the location where they were purchased.
Product photos can be viewed here.
These powdered infant formulas have the potential to be contaminated with Cronobacter, a bacterium that can cause severe foodborne illness primarily in infants. Cronobacter infections are rare but are especially high risk for newborn infants.
Parents and caregivers should never dilute infant formula and should not make or feed homemade infant formula to infants.
More information on Cronobacter and infant formula is available on CDC’s website.
Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths, and abnormal movements. Cronobacter Infection may also cause bowel damage and may spread through the blood to other parts of the body.
If your child is experiencing any of these symptoms, you should notify your child’s healthcare provider and seek medical care for your child immediately. Healthcare providers and health departments are encouraged to report any confirmed cases of Cronobacter sakazakii to CDC.