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Abbott Nutrition
FDA recall F-1041-2016 · Class II · reported 2016-04-13 · Terminated
- 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 .
- Reason
- 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
- Quantity
- 15,609 cases (374,616 units)
- Distribution
- 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.
- Firm location
- VA, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Telephone
- Recall started
- 2016-03-10
- Terminated
- 2016-11-01
- Code info
- List Number 55897 , Lot 57642RA00
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.