Farmalac, Crecelac Infant Formula Recall Issued Over Products Never Approved by FDA

Consumers are advised to stop using the recalled infant formula products immediately and report any health concerns to their healthcare provider.

Crecelac and Farmalac infant formula is being recalled because the manufacturer failed to test the products to confirm they are safe and nutritional for babies, according to warnings issued by federal regulatory officials.

The U.S. Food and Drug Administration (FDA) announced the Crecelac and Farmalac infant formula recall on May 25, indicating that the manufacturer did not submit the required premarket notification. Therefore, consumers are being warned that these products have not been evaluated to determine if they meet federal standards.

To date, no illnesses or other problems have been reported in relation to the recalled infant formula products.

Infant Formula Recalls

This recall is part of a continuing effort by the FDA to ensure the safety of infant formula products, which have been linked to widespread problems with contamination and food poisoning outbreaks in recent years.

The FDA faced sharp criticism following a massive Similac recall in 2022, after it was discovered that the powdered infant formula was widely distributed with cronobacter and salmonella bacteria. Reports subsequently found that the manufacturer knew about the contamination problems for months before the recall was announced, but was able to continue distributing products.

More than 80 Similac food poisoning lawsuits have been filed by parents of children diagnosed with various injuries after consuming that infant formula, alleging that Abbott Laboratories neglected safety standards for profit. As a result of findings from that investigation, the FDA has substantially stepped up regulatory efforts over infant formula manufacturers to protect consumers.


Was your premature child fed Similac or Enfamil?

Premature infants fed Similac or Enfamil cow's milk formula face an increased risk of necrotizing enterocolitis (NEC) or wrongful death.


The recalled Farmalac and Crecelac infant formula products come in 12.4 oz. cardboard and aluminum cans, which were exclusively sold at retail locations in Texas.

The recall includes Crecelac Infant 0-12, with UPC 8 50042 40847 6 and expiration dates of 08/2025 and 09/2025; Farmalac 0-12, with UPC 8 50042 40841 4 and expiration dates of 08/2025 and 09/2025; and Farmalac 0-12 Low Lactose, with UPC 8 50042 40839 1 and expiration dates of 08/2025 and 09/2025.

Consumers who have bought Crecelac Infant 0-12, Farmalac 0-12, or Farmalac 0-12 Low Lactose are advised to stop using the recalled products and return them to the purchase location for a full refund. If there are concerns about injury or illness, they should consult a healthcare provider.

For questions, consumers can contact the Dairy Manufacturers Inc., of Prosper, TX at 1-972-347-2341, Monday to Friday, 9:30 a.m. to 5 p.m. EST.

Infant Formula Lawsuits

Given common questions of fact and law raised in the complaints, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for all lawsuits resulting from the Similac recall, centralizing the claims before U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois.

In order to promote the settlement negotiations, Judge Kennelly has also called for a series of early Similac recall bellwether trials to be held in the federal court system, where the parties will focus on preparing a number of claims to go before juries that are representative of other claim in the litigation.

While the outcome of these bellwether trials will not be binding on other cases, they will be used to help gauge how juries are likely to respond to evidence and testimony which could be repeated in hundreds of separate trials, and may help form the basis of a Similac recall settlement agreement.

A similar process has been established in a separate federal MDL established for all Similac lawsuits over NEC (necrotizing enterocolitis) diagnosed among premature infants fed the cow’s milk-based infant formula.

Dozens of Similac NEC lawsuits and Enfamil NEC lawsuits have been centralized before U.S. District Judge Rebecca R. Pallmeyer, as part of a separate consolidated pretrial proceeding.

Each of those complaints present failure to warn claims against Abbott and Mead Johnson, the manufacturer of the competing cow’s milk-based formula Enfamil, indicating that the companies knew that premature infants faced an increased risk of NEC from their formula, yet false and misleading information has been provided to families and the medical community.


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