The Recall Desk
ModerateFDA (Food)·F-1041-2016·Announced 2016-04-13

Abbott Nutrition Recalls PediaSure Grow & Gain Vanilla Due to Sensory Changes

Abbott Nutrition is recalling PediaSure Grow & Gain Vanilla cans because the product may have an inconsistent color, smell, taste, or texture.

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 involves sensory and physical stability issues (color, smell, taste, texture) rather than a high-risk pathogen or structural defect, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Abbott Nutrition is voluntarily recalling PediaSure Grow & Gain Vanilla, 8 oz. metal cans, due to potential inconsistencies in the product's color, smell, taste, or texture compared to other lots. The recall affects Lot 57642RA00, with a total of 15,609 cases (374,616 units) distributed in the United States between October 12, 2015, and December 4, 2015.

The company identified a complaint trend regarding physical stability and sensory characteristics on January 25, 2016. An investigation revealed the possibility that a small portion of the cans may be affected. The product was distributed to 151 distributors, 32 medical facilities, and 25 other consignees, including 12 US government consignees. No foreign accounts were involved.

Consumers who have purchased this specific lot should check their cans for the lot number 57642RA00. If the product is present, consumers should stop using it and contact Abbott Nutrition for further instructions or a refund.

The recalled product

Product
The product is labeled as follows: PediaSure Grow & Gain Vanilla, Unit size : 8 oz. , Container description : Metal Can, Total package size : 24 cans per case .
Manufacturer
Abbott Nutrition

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 (2)

  • List Number 55897
  • Lot 57642RA00

Distribution

Distribution scope not specified by the agency.