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

Raleigh, N.C., Jan. 14, 2026 — Dairy Manufacturers Inc. of Prosper, Texas, has voluntarily recalled all lot codes of three infant formulas—Crecelac Infant 0–12, Farmalac 0–12 and Farmalac 0–12 Low Lactose—because the products were sold in the U.S. without required FDA premarket notification under 21 CFR 106.110. The primary risk is that these formulas have not been evaluated by the FDA to determine whether they meet U.S. food safety and nutritional standards; consumers should stop using the products immediately and not feed them to infants.

The recalled products are labeled as 12.4 oz cardboard and aluminum cans and have lot code(s) covering all production for the named SKUs with expiration dates 08/2025 and 09/2025. UPCs include 8 50042 40847 6 for Crecelac Infant 0–12, 8 50042 40841 4 for Farmalac 0–12 and 8 50042 40839 1 for Farmalac 0–12 Low Lactose. These products have been sold since May 24, 2024, online and at select U.S. retailers, with initial retail sales reported in Texas; consumers should check their product packaging for the listed UPCs, lot code(s) and expiration dates before taking further action.

Consumers should immediately discontinue use and either return the product to the place of purchase for a full refund or dispose of it safely; customers seeking a refund or replacement may contact Dairy Manufacturers Inc. at 1-972-347-2341 Monday–Friday, 9:30 a.m.–5 p.m. EST, or email [email protected] for assistance and claim instructions. Anyone concerned about possible illness should contact a healthcare provider. For additional information or to verify lot code(s), consumers should refer to the company’s recall notice and the FDA website.