Severity
Moderate
PreGel Lemon 50 4.4 lb (2kg) bag, Ingredients: dextrose, citric acid, mono and diglycerides of fatty acids, propane -1,2-diol esters of fatty acids, maltodextrins, carboxymethylcellulose, guar gum, flavors, dehydrated lemon juice, xanthan gum Manufactured by: PreGel America, Inc., 4450 Fortune Ave. NW Concord, NC 28027 USA Tel. +1 704-707-0300 UPC 0 817304 015148
Reported: September 4, 2019 Initiated: August 2, 2019 #F-2108-2019 179 cs/8/4.4 lb bags units
PreGel America, Inc. issued this FDA Food recall on September 4, 2019. Classified as Moderate severity (Class II). Approximately 179 cs/8/4.4 lb bags units are affected. The recall was issued because: Undeclared Milk. The firm received a complaint that there was milk in the product. The product ingredient statement doe…. 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-2108-2019) was formally reported on September 4, 2019, with the manufacturer initiating the action on August 2, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. PreGel America, Inc. is listed as the recalling firm, operating out of Concord, NC. Federal records indicate 179 cs/8/4.4 lb bags units are affected, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Undeclared Milk. The firm received a complaint that there was milk in the product. The product ingredient statement does not include milk. Distribution data in the federal record shows the product reached: Product was shipped to the following states: AR, CA, CO, DC, FL, GA, HI, IA, IL, IN, KS, MA, MN, MS, NC, NJ, NV, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WI. Product was also shipped to Canada, Guatemala & St. Lucia.. 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 4 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 7 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
179 cs/8/4.4 lb bags
Related Recalls
6
4 from same agency
Product Description
PreGel Lemon 50 4.4 lb (2kg) bag, Ingredients: dextrose, citric acid, mono and diglycerides of fatty acids, propane -1,2-diol esters of fatty acids, maltodextrins, carboxymethylcellulose, guar gum, flavors, dehydrated lemon juice, xanthan gum Manufactured by: PreGel America, Inc., 4450 Fortune Ave. NW Concord, NC 28027 USA Tel. +1 704-707-0300 UPC 0 817304 015148
Reason for Recall
Undeclared Milk. The firm received a complaint that there was milk in the product. The product ingredient statement does not include milk.
Details
- Recalling Firm
- PreGel America, Inc.
- Units Affected
- 179 cs/8/4.4 lb bags
- Distribution
- Product was shipped to the following states: AR, CA, CO, DC, FL, GA, HI, IA, IL, IN, KS, MA, MN, MS, NC, NJ, NV, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WI. Product was also shipped to Canada, Guatemala & St. Lucia.
- Location
- Concord, NC
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | F-2108-2019 |
| Date reported | September 4, 2019 |
| Date initiated | August 2, 2019 |
| Recalling firm | PreGel America, Inc. |
| Units affected | 179 cs/8/4.4 lb bags |
| Distribution | Product was shipped to the following states: AR, CA, CO, DC, FL, GA, HI, IA, IL, IN, KS, MA, MN, MS, NC, NJ, NV, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WI. Product was also shipped to Canada, Guatemala & St. Lucia. |
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? ▼
PreGel Lemon 50 4.4 lb (2kg) bag, Ingredients: dextrose, citric acid, mono and diglycerides of fatty acids, propane -1,2-diol esters of fatty acids, maltodextrins, carboxymethylcellulose, guar gum, flavors, dehydrated lemon juice, xanthan gum Manufactured by: PreGel America, Inc., 4450 Fortune Ave. NW Concord, NC 28027 USA Tel. +1 704-707-0300 UPC 0 817304 015148. Recalled by PreGel America, Inc.. Units affected: 179 cs/8/4.4 lb bags.
Why was this product recalled? ▼
Undeclared Milk. The firm received a complaint that there was milk in the product. The product ingredient statement does not include milk.
Which agency issued this recall? ▼
This recall was issued by the FDA Food on September 4, 2019. Severity: Moderate. Recall number: F-2108-2019.
Where was the recalled product distributed? ▼
Distribution: Product was shipped to the following states: AR, CA, CO, DC, FL, GA, HI, IA, IL, IN, KS, MA, MN, MS, NC, NJ, NV, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WI. Product was also shipped to Canada, Guatemala & St. Lucia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-2108-2019) 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.
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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.
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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).