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  1. Recalls, Market Withdrawals, & Safety Alerts


Pregel America, Inc. Issues Allergy Alert on Undeclared Milk in Lemon 50

This recall has been completed and FDA has terminated this recall.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Reason for Announcement:
Recall Reason Description
Undeclared Milk
Company Name:
PreGel America, Inc.
Brand Name:
Brand Name(s)
Product Description:
Product Description
Lemon 50, powdered flavoring

Company Announcement

PreGel America, Inc. of Concord, North Carolina is voluntarily recalling a single lot of Lemon 50, a powdered flavoring. The product is being recalled due to the possible presence of undeclared milk in the product. People who have an allergy or severe sensitivity to milk run the risk of serious or lifethreatening allergic reaction if they consume this product.

The product was distributed to customers in 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, Canada, Guatemala, and St. Lucia.

The recalled product is identified by the name Lemon 50 with product code 306038 and lot number 381081U279N. The lot number is located on the back of the packaging. The product was produced on April 18, 2018 and has a best before date of April 17, 2020. The product is packaged in 2 kg (4.4 lbs) bags, 8 bags per case.

No other PreGel products or Lemon 50 lot numbers are recalled.

The recall was initiated after it was discovered that several units from the identified lot number tested positive for the presence of milk and were distributed in packaging that did not reveal the presence of milk in the product. A subsequent investigation is ongoing.

No adverse events or reports of illness or injury related to this matter have been reported to date.

PreGel recommends that anyone who purchased or is in possession of the product immediately discontinue use and verify if they retain the affected lot. Those in possession of recalled lot #381081U279N should contact PreGel America at 704-707-0655 for further instruction. Businesses carrying this product should return it to the North American headquarters in Concord, NC for product replacement or credit. PreGel America will arrange for the return of the product at no cost.

If you have questions or inquiries please call this designated line: 704-707-0655, or email QA@pregelamerica.com, Monday – Friday 8:00 a.m. – 5:00 p.m. Eastern Standard Time.

This recall is being made with the knowledge of the US Food and Drug Administration.

Company Contact Information


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