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Recall notice

Crecelac & Farmalac Infant Formula - recalled due to non-compliance with FDA’s infant formula regulations

1 year ago source fda.gov

Texas, United States

Dairy Manufacturers Inc., is voluntarily recalling all lot codes for infant formulas available in the US: Crecelac Infant 0-12, Farmalac 0-12 and Farmalac 0-12 Low lactose to the retail and wholesale level. The products have been found in non-compliance with the requirements of the FDA under section 21 CFR 106.110 New Infant formula registration. Products were sold only in the state of Texas at retail level.

Dairy Manufacturers is conducting this voluntary recall because the products listed were sold in the U.S. without complying with the FDA’s infant formula regulations. This was identified after an FDA notification, because the firm has not submitted the required premarket notification. Parents and caregivers should understand that the products have not been evaluated by FDA to determine whether they meet U.S. food safety and nutritional standards.

The products are labeled as infant formula and are packaged in a cardboard and aluminum can of 12.4 oz. The recalled products are:
Crecelac Infant 0-12. UPC: 8 50042 40847 6. EXP. DATES: 08/2025; 09/2025
Farmalac 0-12. UPC: 8 50042 40841 4. EXP. DATES 08/2025; 09/2025
Farmalac 0-12 Low lactose. UPC: 8 50042 40839 1. EXP. DATES 08/2025; 09/2025

Consumers who have purchased Crecelac Infant 0-12, Farmalac 0-12, and Farmalac 0- 12 low lactose are urged to discontinue the use of the recalled products and return it to the place of purchase for a full refund.

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

In case your child experiences harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Dairy Manufacturers Inc.
Brand name: Crecelac and Farmalac
Product recalled: Infant Formula
Reason of the recall: Food Compliance Programs – Baby Formula
FDA Recall date: May 25, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dairy-manufacturers-inc-issues-voluntary-recall-products-due-non-compliance-requirements-under-21

#babyformula #texas #unitedstates

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