CLASS II Food recall · Reported 13 Apr 2016 · FDA Enforcement Report
The product is labeled as follows recalled by Abbott Nutrition
Abbott Nutrition is recalling The product is labeled as follows: PediaSure Grow & Gain Vanilla, Unit size : , Container. The recall was initiated on 10 Mar 2016 and the FDA has classified it as Class II.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- F-1041-2016
- FDA event ID
- 73499
- Recalling firm
- Abbott Nutrition, Altavista, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Mar 2016
- FDA classified
- 6 Apr 2016
- Reported
- 13 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Product category
- Other
Timeline
| 10 Mar 2016 | Recall initiated by company | |
| 6 Apr 2016 | Classified by FDA | +27 days |
| 13 Apr 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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 .
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
List Number 55897 , Lot 57642RA00
Where was it sold?
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.
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Abbott Nutrition
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS II | Similac Alimentum recalled by Abbott NutritionSimilac Alimentum | Abbott Nutrition | Packaging Defects | MI, OH |
| Food | CLASS II | Promote with Fiber Vanilla metal recalled by Abbott NutritionPromote | Abbott Nutrition | Sterility | PR |
| Food | CLASS II | Nepro Mixed Berry metal recalled by Abbott NutritionNepro | Abbott Nutrition | Sterility | PR |
| Food | CLASS II | Nepro Vanilla High Protein metal recalled by Abbott NutritionNepro | Abbott Nutrition | Sterility | PR |
| Food | CLASS II | Vital High Protein metal recalled by Abbott NutritionVital High | Abbott Nutrition | Sterility | PR |
Other Other recalls
All 4,694| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | ANNOUNCED | Tractor Wheels Organic Toddler Soft-Baked Bars (all lots recalledOnce Upon a Farm | Once Upon a Farm | Choking Hazard | Nationwide |
| Food | CLASS III | Tube Shaped Wheat Snack recalled by El Ruisenor De Mexico | El Ruisenor De Mexico | Undeclared Allergens | 7 states |
| Food | CLASS II | Fritura Rueda / Wheat Wheel Snack recalled by El Ruisenor De MexicoFritura Rueda | El Ruisenor De Mexico | Undeclared Allergens | 7 states |
| Food | CLASS III | Whole Wheat recalled by El Ruisenor De Mexico | El Ruisenor De Mexico | Undeclared Allergens | 7 states |
| Food | CLASS III | Wheat Germ recalled by El Ruisenor De Mexico | El Ruisenor De Mexico | Undeclared Allergens | 7 states |