LittleOak Infant Formula Recalled for Missing FDA Approval and Incorrect Mixing Instructions
The Little Oak Company is recalling LittleOak Natural Goat Milk Follow On Infant Formula Stage 2 due to lack of FDA pre-market notification and mixing instructions not provided in ounces.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an infant formula, a high-risk product category. Although no illnesses or injuries are reported, incorrect mixing instructions could lead to improper formula preparation and potential harm to infants. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
The Little Oak Company Ltd is recalling LittleOak Natural Goat Milk Follow On Infant Formula (Stage 2) because the product was distributed without required FDA pre-market notification and the mixing instructions are not provided in ounces, the standard measurement system used in the United States.
Approximately 15,600 units packaged in 800g (1.8 lbs) tin cans are affected. The product was distributed nationwide across WY, CA, NY, GA, IL, UT, MD, CO, PA, VT, TX, IN, FL, CT, HI, SC, MN, LA, NJ, MI, WA, OH, KY, NM, ID, MO, OK, NV, AR, NE, IA, MA, VA, TN, NC, AK, AV, AL, NH, SD, WI, PR, RI, KS, ME, MT, and DC. The affected product carries Batch No. L-M-23-54, MANF16411 and MANF16564, Product No. FPG006, with best-by dates of 26/5/2025, 17/4/2023, and 5/7/2025.
Consumers should check if they have this product by examining the batch number and best-by date on the tin. If you have purchased this infant formula, consult with your pediatrician or healthcare provider for guidance.
The recalled product
- Product
- LittleOak Natural Goat Milk Follow On Infant Formula (Stage 2); packaged in 800g (1.8lbs) tin cans - six cans per case.
- Manufacturer
- The Little Oak Company Ltd
- Category
- Food — Infant Formula
- Affected units
- 15,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Batch No. L-M-23-54
- MANF16411 and MANF16564 Product No. FPG006 Best By: 26/5/2025
- 17/4/2023
- 5/7/2025
Distribution
Part of a larger recall action
This product is one of 2 recalled by The Little Oak Company Ltd under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · The Little Oak Company Ltd
See all →- HighLittleOak Goat Milk Infant Formula Recalled for Mixing Instructions Not in Ounces
FDA (Food) · 2023-10-18
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