The Recall Desk
HighFDA (Food)·F-0156-2023·Announced 2022-11-23

Similac 360 infant formula recalled for compromised seal integrity

Abbott Laboratories is recalling Similac 360 Total Care infant formula in 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. The affected product has been widely distributed domestically and internationally.

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: This is an FDA Class II recall affecting infant formula with compromised seal integrity in a vulnerable population. Although the hazard (seal compromise enabling spoilage) is theoretical with no reported illnesses or injuries, infant formula represents a risk-of-harm product where contamination or spoilage poses significant risk to infants.

Plain-English summary

Abbott Laboratories is recalling Similac 360 Total Care infant formula in 2 fl oz resealable plastic bottles due to compromised seal integrity. This issue could allow product spoilage. The recall affects 14,588,544 bottles with multiple batch numbers and case numbers, with best-by dates ranging from December 1, 2022 through July 1, 2023.

The affected product was distributed domestically across all 50 U.S. states and the District of Columbia, and internationally to Canada, Puerto Rico, Bermuda, Curacao, Trinidad and Tobago, Panama, Dominican Republic, and Colombia.

Consumers who have purchased affected bottles should stop using them immediately. Check the batch number, case number, and best-by date on your bottle against the list of recalled codes. If you have purchased recalled product, do not use it. Contact Abbott Laboratories or consult with a healthcare provider for further guidance.

No illnesses or injuries have been reported to date. This recall was classified as FDA Class II.

The recalled product

Product
Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
Manufacturer
Abbott Laboratories
Category
Food — Infant Formula
Hazard
  • compromised-seal
  • spoilage
  • food-contamination

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 (20)

  • Batch No. 35609N200
  • 39480N200
  • 39633N200
  • 40624N200
  • 40715N200
  • 40738N200
  • 41001N200
  • 377777N200
  • 41756N200
  • 41793N200
  • 41875N200
  • 40716N200
  • 37778N200
  • 40755N200
  • 4296N200
  • 41754N200
  • 38779N200
  • 40755N200 Case No. 38493XK00
  • 41543XK00
  • 420258H00

Distribution

Distributed in 1 state:

  • DC

Related recalls

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