MODERATE RISK Terminated F-1041-2016

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 .

Recalled by Abbott Nutrition

Classification

Class II — Products that might cause a temporary health problem, or pose only a slight threat of a serious nature.

Reason for Recall

Abbott Nutrition is recalling PediaSure Grow & Gain Vanilla is product because the product may have a different color, smell, taste or texture  inconsistent with other lots of PediaSure Grow & Gain Vanilla. Abbott Nutrition also recognized a complaint trend for physical stability and sensory on this batch on 1/25/16 and an investigation revealed a possibility that a small portion of cans may

Product Details

Product Quantity
15,609 cases (374,616 units)
Product Type
Food
Code Info
List Number 55897 , Lot 57642RA00
Voluntary/Mandated
Voluntary: Firm initiated

Distribution & Geography

Distribution Pattern
Lot 57642RA00, Beginning Date of distribution in US  10/12/15 End Date of distribution in US- 12/4/15 . AN distributed this lot to151 Distributors, 32 Medical Facilities and 25 Other types of consignees (2 of these were internal sales reps). No foreign accounts. There are 12 US government consignees.
Company Location
Altavista, VA, 24517-1132

Timeline

Report Date
04/13/2016
Recall Initiated
03/10/2016
Classification Date
04/06/2016
Termination Date
11/01/2016

Source: U.S. Food & Drug Administration (FDA) — FDA Recalls

Last updated: July 13, 2026

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