FDA - Food and Drug Administration

05/25/2024 | Press release | Distributed by Public on 05/25/2024 10:46

Crecelac and Farmalac (Infant Formula/Dairy Manufacturers Inc.) Recall reason: Food Compliance Programs – Baby Formula


Dairy Manufacturers Inc. Issues Voluntary Recall of Products Due to Non-Compliance with Requirements Under the 21 CFR 106.110 New Infant Formula Registration

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:May 24, 2024FDA Publish Date:May 25, 2024Product Type:Food & Beverages Reason for Announcement:
Recall Reason Description
Food Compliance Programs - Baby Formula
Company Name:Dairy Manufacturers Inc.Brand Name:
Brand Name(s)
Crecelac and Farmalac
Product Description:
Product Description
Infant Formula

Company Announcement

Dairy Manufacturers Inc., of Prosper, TX - 5/24/24, 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.

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. No illnesses have been reported to date.

The products are labeled as infant formula and are packaged in a cardboard and aluminum can of 12.4 oz. Products were sold only in the state of Texas at retail level. The recalled products are:

Crecelac Infant 0-12 8 50042 40847 6 08/2025; 09/2025
Farmalac 0-12 8 50042 40841 4 08/2025; 09/2025
Farmalac 0-12 Low lactose 8 50042 40839 1 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 use of the recalled products and return it to the place of purchase for a full refund. There have been no known reports of injuries or adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers with questions may contact the company at 1-972-347-2341 (Monday to Friday, 9:30 a.m. to 5 p.m. EST).

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

We sincerely apologize for any inconvenience or concern this may cause and assure our customers that we are taking all necessary steps to ensure the safety, quality, and compliance of our products.

Company Contact Information

Consumers:Dairy Manufacturers Inc. 1-972-347-2341

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