The Recall Desk
HighFDA (Food)·F-0158-2023·Announced 2022-11-23

Similac Infant Formula Recalled Due to Compromised Seal Integrity

Abbott Laboratories is recalling Similac 360 Total Care Sensitive infant formula in 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Approximately 15.9 million bottles are affected across the United States and international locations.

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 recall with no reported illnesses or injuries. The hazard—compromised seal integrity potentially causing spoilage—represents a risk-of-harm scenario for a vulnerable population (infants), meeting the criterion for High severity.

Plain-English summary

Similac 360 Total Care Sensitive infant formula in 2 fl oz resealable plastic bottles is being recalled by Abbott Laboratories due to compromised seal integrity. The product is sold in 6-count, 12-count, and 48-count cartons.

The compromised seal integrity could lead to product spoilage. Affected batch numbers include 40561N200, 41843N200, 41882N200, 39354N200, and 41858N200. Associated case numbers and product numbers are listed in the official recall notice. Products with "Best By" dates of April 1, 2023, May 1, 2023, and June 1, 2023 are affected.

Approximately 15,865,104 bottles are involved in this recall. Distribution includes all 50 U.S. states and Washington DC, as well as Canada, Puerto Rico, Bermuda, Curacao, Trinidad, Tobago, Panama, Dominican Republic, and Colombia.

Consumers who have purchased this product should check the batch numbers and best-by dates on their bottles to determine if they have an affected product.

The recalled product

Product
Similac 360 Total Care Sensitive 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
Affected units
15,865,104

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. 40561N200
  • 41843N200
  • 41882N200
  • 39354N200
  • 41858N200
  • 41843N200 Case No. 40561N200
  • 430294R00
  • 430304R00
  • 430314R00
  • 430328H00
  • 430338H00
  • 430348H00
  • 430358H00
  • 430368H00
  • 440408H00 Product No. 68155
  • 68154
  • 68152
  • 68711 Best By 04/01/23
  • 05/01/23
  • 06/01/23

Distribution

Distributed in 50 states:

Part of a larger recall action

This product is one of 12 recalled by Abbott Laboratories under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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