Agency classClass IIOur severity:Moderate FDA (Food)·F-0157-2023·Announced 2022-11-23

Similac 360 Total Care Infant Formula Recalled for Compromised Bottle Seals

Abbott Laboratories is recalling batches of Similac 360 Total Care and Total Care Sensitive infant formula 2 fl oz discharge kits for compromised seal integrity that could allow spoilage. The affected batch is identified by product code 39480N200 with a Best By date of 04/01/23.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II precautionary recall with no reported illnesses or injuries. The hazard is theoretical (potential product spoilage from compromised seals), corresponding to Moderate severity per the recall rubric.

Plain-English summary

Abbott Laboratories is recalling specific batches of Similac 360 Total Care and Similac 360 Total Care Sensitive infant formula due to compromised seal integrity that could lead to product spoilage. The affected product is packaged as 6-count discharge kits containing 2 fl oz resealable plastic bottles.

Affected batches include product code 39480N200 (Case No. 420395E00, Product No. 68264) with a Best By date of 04/01/23. Approximately 14,588,544 bottles have been distributed.

The affected products were distributed domestically across all 50 U.S. states and Washington DC. Internationally, the product was distributed to Canada, Puerto Rico, Bermuda, Curaçao, Trinidad and Tobago, Panama, Dominican Republic, and Colombia.

The recalled product

Product: Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula
Hazard: seal-integrity
spoilage
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 (1)

Batch No. 39480N200 Case No. 420395E00 Product No. 68264 Best By 04/01/23

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 · seal integrity