The Recall Desk
HighFDA (Food)·F-0159-2023·Announced 2022-11-23

Similac 360 Total Care Sensitive infant formula recalled due to compromised seal integrity

Abbott Laboratories is recalling Similac 360 Total Care Sensitive infant formula due to compromised seal integrity that could lead to spoilage. Affected consumers should not use the product and contact Abbott for further instructions.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II classification without reported hospitalizations or illnesses. The hazard is theoretical—compromised seal integrity could lead to spoilage—with no actual cases reported. This is a risk-of-harm product affecting infants, a vulnerable population.

Plain-English summary

Abbott Laboratories is recalling Similac 360 Total Care Sensitive infant formula in 2 fluid ounce reusable plastic bottles packaged as 4-6 count cartons. The recall is due to compromised seal integrity that could allow spoilage of the formula.

The affected product was distributed domestically across all 50 states, Washington DC, and internationally to Canada, Puerto Rico, Bermuda, Curacao, Trinidad and Tobago, Panama, Dominican Republic, and Colombia. This recall affects 14,588,544 bottles.

Consumers who have purchased the affected product should stop using it immediately. Parents and caregivers should contact Abbott Laboratories for instructions on receiving a replacement or refund.

The recalled product

Product
Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton
Manufacturer
Abbott Laboratories
Hazard
  • spoilage
  • compromised-seal

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 (1)

  • Batch No. 35609N200 Case No. 380124R00 Product No. 68130 Best By 12/01/22

Distribution

Distributed in 1 state:

  • DC