The Recall Desk
ModerateFDA (Food)·F-1409-2015·Announced 2015-03-18

Similac Advance Infant Formula Recalled for Chinese Labeling

Abbott Laboratories is recalling Similac Advance infant formula because export-bound product with Chinese labeling was distributed in the US.

What this means for you

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: The recall is classified as FDA Class II, but the hazard is limited to labeling errors (Chinese text on US-bound product) with no reported illnesses or injuries, fitting the 'Minor labeling errors' criterion for a Moderate severity score.

Plain-English summary

Abbott Laboratories is recalling Similac Advance Complete Nutrition Infant Formula with Iron, 1.45lb plastic containers. The recall was initiated after the firm received three consumer calls regarding product with Chinese labeling. An internal investigation revealed that product manufactured for export to China was distributed to three states in the US, and all labeling on these units is in Chinese.

The affected product includes Lot 36499SH05 and Lot 36691SH05, both with an expiration date of January 1, 2016. A total of 51,642 containers were involved in this distribution. According to the structured product information, all product was shipped to New Jersey.

Consumers who have this product should stop using it and contact Abbott Laboratories for a refund or replacement. The recall is classified as FDA Class II, indicating a situation in which there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Similac¿ Advance Complete Nutrition Infant Formula with Iron, 1.45lb plastic container.

Distribution

Distributed in 1 state: