Agency classClass IIOur severity:Moderate FDA (Food)·F-0165-2023·Announced 2022-11-23

Similac Water bottles recalled for compromised seal integrity

Abbott Laboratories is recalling specific lots of Similac Water due to compromised seal integrity that could lead to spoilage. The recall affects 14,588,544 bottles distributed across the US, territories, and international locations.

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 recall involving low-risk contamination (spoilage potential) due to seal compromise. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed, consistent with a precautionary recall.

Plain-English summary

Abbott Laboratories is recalling Similac Water bottles (2 fl oz, sterilized, export product packaged in 48-count cases) due to compromised seal integrity.

The compromised seals could allow spoilage of the product. The recall applies to bottles with Batch No. 39398N200, Case No. 39398N200, Product No. 5100013, and Best By date of 10/01/23.

The affected product was distributed across the United States (all 50 states plus DC), US territories (Puerto Rico, Bermuda, Curacao, Trinidad, Tobago), and international locations (Panama, Dominican Republic, and Colombia). Approximately 14,588,544 bottles are affected by this recall.

If you have purchased the recalled product, do not use it. Consumers with questions or concerns should contact Abbott Laboratories or consult their healthcare provider.

The recalled product

Product: Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Manufacturer: Abbott Laboratories
Category: Food — Bottled Water / Infant Products
Hazard: seal-compromise
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. 39398N200 Case No. 39398N200 Product No. 5100013 Best By 10/01/23

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 compromise