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PreGel America, Inc.
FDA recall F-2108-2019 · Class II · reported 2019-09-04 · Terminated
- Product
- 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
- Undeclared Milk. The firm received a complaint that there was milk in the product. The product ingredient statement does not include milk.
- Quantity
- 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.
- Firm location
- NC, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Recall started
- 2019-08-02
- Terminated
- 2021-12-17
- Code info
- Lot 381081U279N Produced 04/18/2018 Best Before 04/17/2020, Product Code: 306038
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.