FDA warns – Crecelac Infant 0-12 and Farmalac 0-12, 012 Low lactose recalled by Dairy Manufacturers Inc. due to non-compliance

On May 24, 2024, Prosper, Texas-based Dairy Manufacturers Inc. announced a voluntary recall of all lots of US-distributed Crecelac Infant 0-12, Farmalac 0-12 and Farmalac 0-12 Low lactose formulas because the products were found to be out of compliance with FDA requirements outlined under the agency’s section 21 CFR 106.110 New Infant formula registration.

Officials say the recall, initiated at the retail and wholesale level, is a response to a notification from the FDA, which indicated that the company had not submitted the mandatory premarket notification.

Because the products are in non-compliance, parents and caregivers are advised that the products have not been subjected to an FDA evaluation, and therefore the nutrition and food safety of the items may not necessarily meet the agency’s U.S. standards.

Labeled as infant formula, the now-recalled products come packaged in 12.4-ounce cans made of cardboard and aluminum. Affected products were made available for retail purchase in the state of Texas and include:

  • Crecelac Infant 0-12
    • UPC: 8 50042 40847 6
    • Expiration dates: 08/2025; 09/2025
  • Farmalac 0-12
    • UPC:8 50042 40841 4
    • Expiration dates: 08/2025; 09/2025
  • Farmalac 0-12 Low lactose
    • UPC: 8 50042 40839 1
    • Expiration dates: 08/2025; 09/2025

While Dairy Manufacturers Inc. has not been made aware of any related illnesses or adverse reactions to date, anyone who may have purchased Crecelac Infant 0-12, Farmalac 0-12, or Farmalac 0-12 Low lactose should cease use of all products. The items may be brought back to the point of purchase for a complete refund.

Questions or concerns regarding a potential injury or illness after use of the product should be directed to a healthcare professional.

For general questions, the company can be reached at 1-972-347-2341. Calls are monitored Monday through Friday, from 9:30 a.m. to 5:00 p.m. Eastern Time.


Our team at TruLaw works to connect you with the compassionate and reliable legal representation you deserve after a traumatic medical event. If your child has suffered an adverse health outcome after using an FDA non-compliant infant formula product, our attorneys are prepared to support you through the next steps. To get started, contact us online or take our free Instant Case Evaluation ℠