Severity
Moderate
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 .
Reported: April 13, 2016 Initiated: March 10, 2016 #F-1041-2016 15,609 cases (374,616 units) units
Abbott Nutrition issued this FDA Food recall on April 13, 2016. Classified as Moderate severity (Class II). Approximately 15,609 cases (374,616 units) units are affected. The recall was issued because: Abbott Nutrition is recalling PediaSure Grow & Gain Vanilla is product because the product may have a different color, …. This recall notice is sourced from official FDA Food enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Food action (record #F-1041-2016) was formally reported on April 13, 2016, with the manufacturer initiating the action on March 10, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Abbott Nutrition is listed as the recalling firm, operating out of Altavista, VA. Federal records indicate 15,609 cases (374,616 units) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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 th…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Food. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
15,609 cases (374,616 units)
Related Recalls
6
6 from same agency
Product Description
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 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
Details
- Recalling Firm
- Abbott Nutrition
- Units Affected
- 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.
- Location
- Altavista, VA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | F-1041-2016 |
| Date reported | April 13, 2016 |
| Date initiated | March 10, 2016 |
| Recalling firm | Abbott Nutrition |
| Units affected | 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 sa… |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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. Units affected: 15,609 cases (374,616 units).
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Food on April 13, 2016. Severity: Moderate. Recall number: F-1041-2016.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-1041-2016) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product? ▼
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.
Recall Guides
Learn how the US recall system works and how to protect yourself and your household.
How the US Recall System Works
The three federal agencies, how recalls are initiated, and what happens next.
Understanding Recall Severity Classes
What Class I, II, and III mean and which recalls demand immediate action.
What to Do When a Product Is Recalled
Verify, claim your remedy, report injuries, and navigate the process.
How to Check If Your Products Are Recalled
Step-by-step guide to checking food, products, medications, and vehicles.
Recalled Products in Your Home
A room-by-room household audit guide for active recalls.
Most Recalled Product Categories
Rankings of highest-recall categories from FDA, CPSC, and NHTSA.
Recall Context
Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
Related Safety Data
Explore related product safety and public health data from federal sources.
Food Safety Inspections
FDA and state food facility inspection results — violations, enforcement actions, and compliance history for food manufacturers and processors.
PlainFoodSafe →
Ingredient Safety Data
FDA food additive and ingredient safety database — regulatory status, usage limits, and safety assessments for thousands of ingredients.
PlainIngredients →
Nutrition Data
USDA nutrition facts for 2M+ food items — calories, macros, vitamins, and ingredient analysis to verify what you consume.
GetFoodFacts →
Drug Safety Information
FDA drug data for 680+ medications — interactions, alternatives, side effects, and safety information for recalled and active drugs.
PlainMeds →
Product Injury Data
CPSC emergency room injury data for 838 product categories — 7.3M NEISS records tracking real-world consumer product injuries.
PlainSafety →
Recall Checker
Search our database of 83K+ recalls by product name, brand, or recall number across all agencies.
Check Now →
Recall Radar
Live feed of the latest recalls across FDA, CPSC, NHTSA, and USDA — filter by agency and severity.
View Radar →
Nearby Recalls in This Category
Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
FDA Food Moderate
Lowes Foods sour cream and onion flavored potato chips, 8oz. bag, UPC 7 41643 05576 6, 9 retail units per case
Uncle Ray's LLC · 2026-03-18
FDA Food Moderate
Frozen Raw Bulk 9 inch Blueberry Crumble Pie ES (4 pies/case). Net wt. 38oz. UPC 00022518893257. Handmade - Willamette…
Willamette Valley Pie Company, LLC · 2026-03-18
FDA Food Critical
Made Fresh Salads brand Whipped Cream Cheese; 5 lb white plastic tub
Made Fresh Salads Inc · 2026-03-18
FDA Food Critical
Made Fresh Salads brand Lox Cream Cheese; 5 lb white plastic tub
Made Fresh Salads Inc · 2026-03-18
FDA Food Critical
Made Fresh Salads brand Scallion Cream Cheese; 5 lb white plastic tub
Made Fresh Salads Inc · 2026-03-18
Compare this recall with Lowes Foods sour cream and onion flavored potato chips, 8oz… →
Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).