Infant Formulas Marketed in the U.S.
All infant formula products sold in the U.S., whether produced domestically or internationally, must meet all U.S. requirements, including those for safety and nutritional adequacy. Infant formula manufacturers are required to register and “notify” an infant formula to FDA at least 90 days before marketing the infant formula in the United States. Failure to provide the required premarket notification is prohibited under the Federal Food, Drug, and Cosmetic Act.
Caregivers should use caution when ordering imported infant formula products online or from third party distributors because these products may not meet U.S. requirements for safety and/or nutritional adequacy. Additionally, important information about product issues or recalls for those infant formulas may not reach caregivers.
The following tables include a listing of all non-exempt and exempt infant formulas that are currently available on the U.S. market.
- Non-exempt infant formulas (Table 1) are routine formulas intended for healthy, term infants.
- Exempt infant formulas (Table 2) are represented and labeled for use by infants who have inborn errors of metabolism (e.g., phenylketonuria [PKU]) or low birth weight, or who otherwise have unusual medical or dietary problems (21 CFR 107.3). Some exempt infant formula products are available on retail shelves or websites for general purchase, while others are prescribed by a physician and must be requested from a pharmacy or infant formula manufacturer, and/or are distributed directly to institutions such as hospitals, clinics, and State or Federal agencies.
This list is provided as a service to anyone using FDA’s website and does not represent FDA endorsement of these products. The directions for use of these products provided on the product label/labeling or by the health care provider should be followed. The FDA cannot ensure that the information on this list is the most current. As the agency becomes aware of newer information, the list will be periodically updated.
Table 1. Non-exempt infant formulas
(Note: Product names are listed to reflect the wording from manufacturer’s labels as submitted to FDA. While some names may appear to be listed differently or formatted inconsistently, the names listed below are matched to the product labeling in FDA records.)
| Aptamil Care Infant Formula Milk-Based Powder with Iron, Stage 1, 0-12 months |
| Aptamil Care Infant Formula Milk-Based Powder with Iron, Stage 2, 6-12 months |
| Baby’s Only Mehadrin Infant Formula Milk-Based Powder with Iron |
| Bobbie Organic Gentle Infant Formula Milk-Based Powder with Iron |
| Bobbie Organic Infant Formula Milk-Based Powder with Iron |
| Bobbie Organic Whole Milk Infant Formula Milk-Based Powder with Iron |
| Bobbie Whole Milk Infant Formula Milk-Based Powder with Iron |
| Bobbie Whole Milk Infant Formula Milk-Based Powder with Iron |
| Bubs 365 Day Grass Fed Infant Formula with Iron Cow Milk-Based Powder |
| Bubs Essential Infant Formula with Iron Cow Milk-Based Powder |
| Bubs Goat Infant Formula with Iron Goat Milk-Based Powder |
ByHeart Whole Nutrition Infant Formula Milk-Based Powder with Iron (Note: this formula has been recalled and there is an ongoing outbreak investigation) |
| Comforts Advantage Premium Infant Formula Milk-Based Powder with Iron (Kroger) |
| Comforts Gentle Premium Infant Formula Milk-Based Powder with Iron (Kroger) |
| Comforts Infant Premium Infant Formula Milk-Based Powder with Iron (Kroger) |
| Comforts Sensitivity Premium Infant Formula Milk-Based Powder with Iron (Kroger) |
| CVS Health Advantage Infant Formula with Iron Milk-Based Powder |
| CVS Health Advantage Premium Infant Formula Milk-Based Powder with Iron |
| CVS Health Gentle Infant Formula with Iron Milk-Based Powder |
| CVS Health Gentle Premium Infant Formula Milk-Based Powder with Iron |
| CVS Health Infant Infant Formula with Iron Milk-Based Powder |
| CVS Health Infant Premium Infant Formula with Iron Milk-Based Powder |
| CVS Health Sensitivity Infant Formula with Iron Milk-Based Powder |
| CVS Health Sensitivity Premium Infant Formula Milk-Based Powder with Iron |
| Earth’s Best Organic Dairy Infant Formula with Iron Milk-Based Powder |
| Earth’s Best Organic Gentle Infant Formula with Iron Milk-Based Powder |
| Earth’s Best Organic Sensitivity Infant Formula with Iron Milk-Based Powder |
| Enfamil 24 Infant Formula Milk-Based with Iron, Ready-to-Use |
| Enfamil A.R. Infant Formula Milk-Based Powder with Iron |
| Enfamil A.R. Infant Formula Milk-Based with Iron, Ready-to-Use |
| Enfamil Gentlease Infant Formula Milk-Based Powder with Iron |
| Enfamil Infant Formula Milk-Based Powder with Iron |
| Enfamil Infant Formula Milk-Based with Iron, Concentrated Liquid |
| Enfamil Infant Formula Milk-Based with Iron, Ready-to-Use |
| Enfamil NeuroPro Care Infant Formula Milk-Based Powder with Iron |
| Enfamil NeuroPro Gentlease Care Infant Formula Milk-Based Powder with Iron |
| Enfamil NeuroPro Gentlease Infant Formula Milk-Based Powder with Iron |
| Enfamil NeuroPro Gentlease Infant Formula Milk-Based with Iron, Ready-to-Use |
| Enfamil NeuroPro Infant Formula Milk-Based Powder with Iron |
| Enfamil NeuroPro Infant Formula Milk-Based with Iron, Ready-to-Use |
| Enfamil Optimum Gentlease Infant Formula Milk-Based Powder with Iron |
| Enfamil Optimum Gentlease Infant Formula Milk-Based with Iron, Ready-to-Use |
| Enfamil Optimum Infant Formula Milk-Based Powder with Iron |
| Enfamil Optimum Infant Formula Milk-Based with Iron, Ready-to-Use |
| Enfamil ProSobee Simply Plant-Based Infant Formula Soy-Based Powder with Iron |
| Enfamil ProSobee Simply Plant-Based Infant Formula Soy-Based with Iron, Concentrated Liquid |
| Enfamil ProSobee Simply Plant-Based Infant Formula Soy-Based with Iron, Ready-to-Use |
| Enfamil Reguline Infant Formula Milk-Based Powder with Iron |
| Good Start Dr. Brown’s Gentle Pro Infant Formula Milk-Based Powder with Iron |
| Good Start Dr. Brown’s Soothe Pro Infant Formula Milk-Based Powder with Iron |
| Good Start Dr. Brown’s Soy-Ease Pro Infant Formula Soy-Based Powder with Iron |
| HappyBaby Organics A2 Organic Infant Formula Milk-Based Powder with Iron |
| HappyBaby Organics Organic Infant Formula Milk-Based Powder with Iron, Stage 1, 0-12 months |
| HappyBaby Organics Organic Infant Formula Milk-Based Powder with Iron, Stage 2, 6-12 months |
| HEB Baby Advantage Premium Infant Formula Milk-Based Powder with Iron |
| HEB Baby Complete Comfort Premium Infant Formula Milk-Based Powder with Iron |
| HEB Baby Gentle Infant Formula Milk-Based Powder with Iron |
| HEB Baby Gentle Premium Infant Formula Milk-Based Powder with Iron |
| HEB Baby Infant Infant Formula Milk-Based Powder with Iron |
| HEB Baby Infant Premium Infant Formula Milk-Based Powder with Iron |
| HEB Baby Sensitivity Premium Infant Formula Milk-Based Powder with Iron |
| HEB Baby Soy Infant Formula Soy-Based Powder with Iron |
| Kabrita Goat Milk-Based Infant Formula Powder with Iron |
| Kendamil Goat Infant Formula Goat Milk-Based Powder with Iron |
| Kendamil Infant Formula Milk-Based Powder with Iron |
| Kendamil Organic Infant Formula Milk-Based Powder with Iron |
| Kirkland Signature ProCare Gentle Infant Formula Milk-Based Powder with Iron (Costco) |
| Kirkland Signature ProCare Infant Formula Milk-Based Powder with Iron (Costco) |
| Mama Bear Advantage Premium Infant Formula Milk-Based Powder with Iron (Amazon) |
| Mama Bear Gentle Premium Infant Formula Milk-Based Powder with Iron (Amazon) |
| Mama Bear Infant Premium Infant Formula Milk-Based Powder with Iron (Amazon) |
| Mama Bear Sensitivity Premium Infant Formula Milk-Based Powder with Iron (Amazon) |
| Mama Bear Soy Infant Formula Soy-Based Powder with Iron (Amazon) |
| Meijer Advantage Infant Formula Milk-Based Powder with Iron |
| Meijer Advantage Premium Infant Formula Milk-Based Powder with Iron |
| Meijer Complete Comfort Premium Infant Formula Milk-Based Powder with Iron |
| Meijer Gentle Infant Formula Milk-Based Powder with Iron |
| Meijer Gentle Premium Infant Formula Milk-Based Powder with Iron |
| Meijer Infant Infant Formula Milk-Based Powder with Iron |
| Meijer Infant Premium Infant Formula Milk-Based Powder with Iron |
| Meijer Sensitivity Infant Formula Milk-Based Powder with Iron |
| Meijer Sensitivity Premium Infant Formula Milk-Based Powder with Iron |
| Meijer Soy Infant Formula with Iron Soy-Based Powder |
| Member’s Mark Advantage Premium Infant Formula Milk-Based Powder with Iron (Sam's Club) |
| Member’s Mark Gentle Premium Infant Formula Milk-Based Powder with Iron (Sam's Club) |
| Member’s Mark Infant Premium Infant Formula Milk-Based Powder with Iron (Sam's Club) |
| Member’s Mark Sensitivity Premium Infant Formula Milk-Based Powder with Iron (Sam's Club) |
| Nara Organics Whole Milk Organic Infant Formula Milk-Based Powder with Iron |
| Parent’s Choice Advantage Infant Formula Milk-Based Powder with Iron (Walmart) |
| Parent’s Choice Advantage Premium Infant Formula Milk-Based Powder with Iron (Walmart) |
| Parent’s Choice Gentle Infant Formula Milk-Based Powder with Iron (Walmart) |
| Parent’s Choice Gentle Premium Infant Formula Milk-Based Powder with Iron (Walmart) |
| Parent’s Choice Infant Infant Formula Milk-Based Powder with Iron (Walmart) |
| Parent’s Choice Infant Premium Infant Formula Milk-Based Powder with Iron (Walmart) |
| Parent’s Choice Sensitivity Infant Formula Milk-Based Powder with Iron (Walmart) |
| Parent’s Choice Sensitivity Premium Infant Formula Milk-Based Powder with Iron (Walmart) |
| Parent’s Choice Soy Infant Formula with Iron Soy-Based Powder (Walmart) |
| Signature Select Advantage Premium Infant Formula Milk-Based Powder with Iron (Albertsons) |
| Signature Select Gentle Premium Infant Formula Milk-Based Powder with Iron (Albertsons) |
| Signature Select Infant Premium Infant Formula Milk-Based Powder with Iron (Albertsons) |
| Signature Select Sensitivity Premium Infant Formula Milk-Based Powder with Iron (Albertsons) |
| Similac 360 Total Care Milk-Based Powder Infant Formula with Iron |
| Similac 360 Total Care Milk-Based Ready-to-Feed Infant Formula with Iron |
| Similac 360 Total Care Sensitive Milk-Based Powder Infant Formula with Iron |
| Similac 360 Total Care Sensitive Milk-Based Ready-to-Feed Infant Formula with Iron |
| Similac Advance Kosher (Cholov Yisroel) Ready-to-Feed Milk-Based Infant Formula with Iron |
| Similac Advance Lamehadrin Milk-Based Powder Infant Formula with Iron |
| Similac Advance Milk-Based Infant Formula with Iron Concentrated Liquid |
| Similac Advance Milk-Based Powder Infant Formula with Iron |
| Similac Advance Milk-Based Ready-to-Feed Infant Formula with Iron |
| Similac Dual Prebiotic Blend Milk-Based Powder Infant Formula with Iron |
| Similac Dual Prebiotic Blend Milk-Based Ready-to-Feed Infant Formula with Iron |
| Similac for Spit-Up Milk-Based Ready-to-Feed Infant Formula with Iron |
| Similac Irish Farms Milk-Based Powder Infant Formula with Iron (formerly Pure Bliss by Similac Irish Farms) |
| Similac Organic Milk-Based Powder Infant Formula with Iron (formerly Pure Bliss by Similac Organic) |
| Similac Organic Milk-Based Ready-to-Feed Infant Formula with Iron (formerly Pure Bliss by Similac Organic) |
| Similac Organic with A2 Milk Milk-Based Powder Infant Formula with Iron (formerly Pure Bliss by Similac Organic with A2 Milk) |
| Similac Pro-Total Comfort Milk-Based Powder Infant Formula with Iron |
| Similac Pro-Total Comfort Milk-Based Ready-to-Feed Infant Formula with Iron |
| Similac Sensitive Milk-Based Infant Formula with Iron Concentrated Liquid |
| Similac Sensitive Milk-Based Powder Infant Formula with Iron |
| Similac Sensitive Milk-Based Ready-to-Feed Infant Formula with Iron |
| Similac Soy Isomil Soy-Based Infant Formula with Iron Concentrated Liquid |
| Similac Soy Isomil Soy-Based Powder Infant Formula with Iron |
| Similac Soy Isomil Soy-Based Ready-to-Feed Infant Formula with Iron |
| Similac Total Comfort Milk-Based Powder Infant Formula with Iron |
| Similac with Iron 24 Cal Milk-Based Ready-to-Feed Infant Formula with Iron |
| Tippy Toes Advantage Premium Infant Formula Milk-Based Powder with Iron (Topco) |
| Tippy Toes Gentle Premium Infant Formula Milk-Based Powder with Iron (Topco) |
| Tippy Toes Infant Premium Infant Formula Milk-Based Powder with Iron (Topco) |
| Tippy Toes Sensitivity Premium Infant Formula Milk-Based Powder with Iron (Topco) |
| Up&Up Advantage Infant Formula with Iron Milk-Based Powder (Target) |
| Up&Up Advantage Premium Infant Formula with Iron Milk-Based Powder (Target) |
| Up&Up Gentle Infant Formula with Iron Milk-Based Powder (Target) |
| Up&Up Gentle Premium Infant Formula with Iron Milk-Based Powder (Target) |
| Up&Up Infant Premium Infant Formula with Iron Milk-Based Powder (Target) |
| Up&Up Sensitivity Premium Infant Formula with Iron Milk-Based Powder (Target) |
| Up&Up Soy Infant Formula with Iron Soy-Based Powder (Target) |
| Walgreens Advantage Premium Infant Formula Milk-Based Powder with Iron |
| Walgreens Gentle Premium Infant Formula Milk-Based Powder with Iron |
| Walgreens Infant Premium Infant Formula Milk-Based Powder with Iron |
| Walgreens Sensitivity Premium Infant Formula Milk-Based Powder with Iron |
| Wellsley Farms Advantage Premium Infant Formula Milk-Based Powder with Iron (BJ’s) |
| Wellsley Farms Gentle Premium Infant Formula Milk-Based Powder with Iron (BJ’s) |
| Wellsley Farms Infant Premium Infant Formula Milk-Based Powder with Iron (BJ’s) |
| Wellsley Farms Sensitivity Premium Infant Formula Milk-Based Powder with Iron (BJ’s) |
Table 2. Exempt infant formulas
(Note: Product names are listed to reflect the wording from manufacturer’s labels as submitted to FDA. While some names may appear to be listed differently or formatted inconsistently, the names listed below are matched to the product labeling in FDA records.)
| Generally Available at Retail |
| Alfamino Infant Infant Formula with Iron Amino Acid-Based Powder |
| EleCare Hypoallergenic Amino Acid-Based Powder Infant Formula with Iron |
| Enfamil NeuroPro EnfaCare Infant Formula Milk-Based Powder with Iron |
| Enfamil NeuroPro EnfaCare Infant Formula Milk-Based with Iron, Ready-to-Use |
| Extensive HA Infant Formula with Iron Extensively Hydrolyzed Powder |
| Neocate Infant Hypoallergenic Amino Acid-Based Powder Infant Formula with Iron |
| Neocate Syneo Infant Hypoallergenic Amino Acid-Based Powder Infant Formula with Iron |
| Nutramigen Hypoallergenic Infant Formula Ready-to-Use with Iron |
| Nutramigen Hypoallergenic Infant Formula with Iron, Concentrated Liquid |
| Nutramigen with Probiotic LGG Hypoallergenic Infant Formula Powder with Iron |
| Parent’s Choice Hypoallergenic Infant Formula Powder with Iron (Walmart) |
| Pepticate Infant Hypoallergenic Powder Infant Formula with Iron |
| Pregestimil 20 Cal Hypoallergenic Infant Formula Ready-to-Use with Iron |
| Pregestimil 24 Cal Hypoallergenic Infant Formula Ready-to-Use with Iron |
| Pregestimil Hypoallergenic Infant Formula Powder with Iron |
| PurAmino DHA & ARA Hypoallergenic Infant Formula Amino Acid-Based Powder with Iron |
| Similac Alimentum Hypoallergenic Powder Infant Formula with Iron |
| Similac Alimentum Hypoallergenic Ready-to-Feed Infant Formula with Iron |
| Similac NeoSure 22 Cal Milk-Based Powder Infant Formula with Iron |
| Similac NeoSure 22 Cal Milk-Based Ready-to-Feed Infant Formula with Iron |
| Up&Up Hypoallergenic Infant Formula Powder with Iron (Target) |
| Not Generally Available at Retail |
| 3232A Infant Formula & Medical Food: Protein Hydrolysate Base Powder with Iron for use with added Carbohydrate |
| Abbott Liquid Protein Fortifier, Extensively Hydrolyzed Protein |
| BCAD 1 Infant Formula & Medical Food: Isoleucine-, Leucine- and Valine-Free Iron Fortified Powder |
| Calcilo XD Low Calcium / Vitamin D-Free Infant Formula with Iron Powder |
| Cyclinex–1 Amino Acid-Modified Infant Formula with Iron Powder – Nonessential Amino Acid-Free |
| Enfamil Human Milk Fortifier Liquid - High Protein (4 g protein) |
| Enfamil Human Milk Fortifier Liquid - Standard Protein (3.4 g protein) |
| Enfamil Liquid Protein Fortifier, Extensively Hydrolyzed Protein |
| Enfamil Premature 20 Cal Infant Formula Milk-Based with Iron, Ready-to-Use |
| Enfamil Premature 24 Cal Infant Formula Milk-Based with Iron, Ready-to-Use |
| Enfamil Premature 30 Cal Infant Formula Milk-Based with Iron, Ready-to-Use |
| Enfamil Premature High Protein 24 Cal Infant Formula Milk-Based with Iron, Ready-to-Use |
| Enfaport Infant Formula Ready-to-Use Milk-Based with Iron |
| Fortini Infant Formula with Iron, Ready-to-Feed |
| GA Infant Formula & Medical Food: Lysine- and Tryptophan-Free Iron Fortified Powder |
| GA–1 Anamix Early Years Amino Acid-Based, Lysine-Free and Tryptophan-Low Powdered Infant Formula with Iron |
| Glutarex–1 Amino Acid-Modified Infant Formula with Iron Powder – Lysine and Tryptophan-Free |
| HCU Anamix Early Years Amino Acid-Based, Methionine-Free Powdered Infant Formula with Iron |
| HCY 1 Infant Formula & Medical Food: Methionine-Free Iron Fortified Powder |
| Hominex–1 Amino Acid-Modified Infant Formula with Iron Powder – Methionine-Free |
| IVA Anamix Early Years Amino Acid-Based, Leucine-Free Powdered Infant Formula with Iron |
| I-Valex–1 Amino Acid-Modified Infant Formula with Iron Powder – Leucine-Free |
| Ketonex–1 Amino Acid-Modified Infant Formula with Iron Powder – Isoleucine-, Leucine-, and Valine-Free |
| LMD Infant Formula & Medical Food: Leucine-Free Iron Fortified Powder |
| MMA/PA Anamix Early Years Amino Acid-Based, Methionine-, Threonine- and Valine-Free, Isoleucine-Low Powdered Infant Formula with Iron |
| MSUD Anamix Early Years Amino Acid-Based, Valine-, Leucine- and Isoleucine-Free Powdered Infant Formula with Iron |
| OA 1 Infant Formula & Medical Food: Isoleucine-, Methionine-, Threonine- & Valine-Free Iron Fortified Powder |
| Phenex–1 Amino Acid-Modified Infant Formula with Iron Powder – Phenylalanine-Free |
| Phenyl-Free 1 Infant Formula & Medical Food: Phenylalanine-Free Iron Fortified Powder |
| PKU Periflex Early Years Amino Acid-Based, Phenylalanine-Free Powdered Infant Formula with Iron |
| PKU start Amino Acid-Based Powdered Phenylalanine-free Infant Formula with Iron |
| Prolact +10 H2MF Human Milk Fortifier (Human, Pasteurized) Liquid |
| Prolact +4 H2MF Human Milk Fortifier (Human, Pasteurized) Liquid |
| Prolact +6 H2MF Human Milk Fortifier (Human, Pasteurized) Liquid |
| Prolact +8 H2MF Human Milk Fortifier (Human, Pasteurized) Liquid |
| Prolact CR Human Milk Caloric Fortifier (Human, Pasteurized) Liquid |
| Prolact RTF 24 Human Milk-Based Premature Infant Formula Ready-to-Feed Liquid |
| Prolact RTF 26 Human Milk-Based Premature Infant Formula Ready-to-Feed Liquid |
| Prolact RTF 28 Human Milk-Based Premature Infant Formula Ready-to-Feed Liquid |
| Pro-Phree Protein-Free Energy Module with Iron, Vitamins & Minerals Powder |
| Propimex–1 Amino Acid-Modified Infant Formula with Iron Powder – Methionine- and Valine-Free, Low in Isoleucine and Threonine |
| ProViMin Protein-Vitamin-Mineral Module with Iron Powder |
| RCF No Added Carbohydrate Soy Infant Formula Base with Iron Concentrated Liquid |
| Similac Human Milk Fortifier Extensively Hydrolyzed Protein Liquid |
| Similac Human Milk Fortifier Liquid |
| Similac PM 60/40 Low-Iron Infant Formula Powder |
| Similac Special Care Premature 20 Cal Milk-Based Infant Formula with Iron, Ready-to-Feed |
| Similac Special Care Premature 24 Cal High Protein Milk-Based Infant Formula with Iron, Ready-to-Feed |
| Similac Special Care Premature 24 Cal Milk-Based Infant Formula with Iron, Ready-to-Feed |
| Similac Special Care Premature 30 Cal Milk-Based Infant Formula with Iron, Ready-to-Feed |
| SOD Anamix Early Years Amino Acid-Based, Methionine- and Cystine-Free Powdered Infant Formula with Iron |
| Surgifort Human Milk Fortifier (Human, Pasteurized) Liquid |
| TYR Anamix Early Years Amino Acid-Based, Tyrosine- and Phenylalanine-Free Powdered Infant Formula with Iron |
| Tyrex–1 Amino Acid-Modified Infant Formula with Iron Powder – Phenylalanine- and Tyrosine-Free |
| TYROS 1 Infant Formula & Medical Food: Phenylalanine- and Tyrosine-Free Iron Fortified Powder |
| WND 1 Infant Formula & Medical Food: Non-Essential Amino Acid-Free Iron Fortified Powder |