MODERATE RISK Terminated F-0919-2021

Holle Goat Stage 1 Organic Infant Milk Formula

Recalled by Able Groupe Inc

Classification

Class II — Products that might cause a temporary health problem, or pose only a slight threat of a serious nature.

Reason for Recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

Product Details

Product Quantity
76,000 units total
Product Type
Food
Code Info
All codes
Voluntary/Mandated
Voluntary: Firm initiated

Distribution & Geography

Distribution Pattern
All sales are direct from firm website - littlebundle.com
Company Location
Sparks, NV, 89431-6428

Timeline

Report Date
08/25/2021
Recall Initiated
08/08/2021
Classification Date
09/01/2021
Termination Date
09/08/2021

Source: U.S. Food & Drug Administration (FDA) — FDA Recalls

Last updated: August 28, 2026

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