The Recall Desk
HighFDA (Food)·F-0160-2023·Announced 2022-11-23

Similac Neosure Infant Formula Recalled Due to Compromised Seal Integrity

Abbott Laboratories is recalling Similac Neosure 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Approximately 14.5 million bottles distributed nationwide and internationally are affected.

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 FDA Class II recall involves a theoretical hazard (potential spoilage due to compromised seal integrity) with no reported illnesses or injuries. As an infant formula product, it qualifies as a risk-of-harm product, supporting a High severity rating.

Plain-English summary

Abbott Laboratories is recalling Similac Neosure 2 fl oz reclosable plastic bottles due to compromised seal integrity that could lead to product spoilage.

The affected bottles were distributed nationwide across all U.S. states and territories, as well as internationally to Canada, Puerto Rico, Bermuda, Curacao, Trinidad, Tobago, Panama, Dominican Republic, and Colombia. The recall involves approximately 14.5 million bottles with Batch No. 35612N200 and a best-by date of 12/01/22.

Consumers with affected bottles should discontinue use. Parents and caregivers should consult with their healthcare provider about appropriate nutrition for infants while a replacement product is obtained.

The recalled product

Product
Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Manufacturer
Abbott Laboratories
Category
Food — Infant Formula
Hazard
  • compromised-seal
  • spoilage

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. 35612N200 Case No. 35612N200 Product No. 56177 Best By 12/01/22

Distribution

Distributed in 1 state:

  • DC

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