Infant formula recall, non-compliance warning issued

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The Texas-based company has filed suit against the U.S. Food and Drug Administration (FDA) Requirements.

Prosper Dairy Manufacturers Inc. announced that it is voluntarily recalling all lot codes of three infant formula products sold in the U.S. — Creserac Infant 0-12, Pharmalac 0-12 and Pharmalac 0-12 Low Lactose. The FDA published the company’s announcement. website Saturday.

These products were recalled because they were sold in the United States without complying with FDA infant formula requirements. These products were sold in violation of FDA’s Title 21 of the Code of Federal Regulations, which requires that anyone responsible for the manufacture or distribution of a new infant formula register that product with FDA before introducing it into interstate commerce.

Infant formula stock photo. A Texas-based company has recalled its infant formula products after they were found to not comply with U.S. Food and Drug Administration regulations.iStock

“This became known following FDA notification because the company had not submitted required premarket notification,” the announcement said.

“Parents and guardians should [the] The FDA will determine whether it meets U.S. food safety and nutrition standards.”

According to the announcement, no illnesses have been reported to date in connection with the recalled products.

The products in question were labeled as infant formula, packaged in 12.4-ounce cardboard and aluminum cans with best-before dates of August and September 2025, and were only sold at retail stores in Texas.

Consumers who purchased Crecelac Infant 0-12, Farmalac 0-12 and Farmalac 0-12 Low Lactose are urged to stop using the recalled products and return them to their place of purchase for a full refund.

The company said there have been no reports of illness or side effects from taking these products, but anyone concerned about illness should consult their health care provider.

“We deeply apologize for any inconvenience or concern this may have caused, and we assure our customers that we are taking all necessary measures to ensure the safety, quality and compliance of our products,” the company said.

If you have any questions, please contact us at 1-972-347-2341, Monday through Friday, 9:30am to 5pm EST.

Recalls are typically issued when there is concern that a product may be harmful to consumers in some way, such as if the product may be contaminated or if allergens are not disclosed in a mislabeled product.

Earlier this month, a Washington-based company Goat Milk Mix Recipe Kits Recalled On FDA advice, this product has been discontinued because it does not provide adequate nutrition when used as an infant formula.

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