Agency classClass IIOur severity:High FDA (Food)·F-0161-2023·Announced 2022-11-23

Similac Total Comfort infant formula recalled for compromised seal integrity

Abbott Laboratories is recalling Similac Total Comfort 2 fl oz bottles due to compromised seal integrity that could allow spoilage. Approximately 14.5 million bottles are affected across the US and international markets.

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 3/5 (High).

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 of infant formula with compromised seal integrity. While no illnesses have been reported, infant formula is a critical product for vulnerable infants, and seal compromise that could lead to spoilage poses a risk of harm to this high-risk population.

Plain-English summary

Abbott Laboratories is recalling Similac Total Comfort infant formula in 2 fl oz reclosable plastic bottles due to compromised seal integrity that could allow spoilage. This is an FDA Class II recall.

The affected bottles were distributed domestically throughout the United States and internationally to Canada, Puerto Rico, Bermuda, Curacao, Trinidad, Tobago, Panama, Dominican Republic, and Colombia. The affected batch numbers are 38793N200, 39500N200, and 41802N200, with Best By dates of 12/01/22, 01/01/23, and 03/01/23. Approximately 14.5 million bottles have been recalled.

Consumers who have these products should stop use immediately. Parents and caregivers should contact Abbott Laboratories or consult their healthcare provider if they have questions or believe they purchased affected bottles.

The recalled product

Product: Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula
Hazard: spoilage
seal-integrity
Affected units: 14,588,544

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 (6)

Batch No. 38793N200
39500N200
41802N200 Case No. 38793N200
41802N200 Product No. 67132 Best By 12/01/22
01/01/23
03/01/23

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 →

Same manufacturer · Abbott Laboratories

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Same hazard · spoilage