Class I Recall — Risk of Serious Adverse Health Consequences or Death

Able Groupe Inc Holle Bio Stage PRE Organic Infant Milk Formula Recall 2021

Official title: Holle Bio Stage PRE Organic Infant Milk Formula

FoodBy Recall Watch Editorial TeamAugust 8, 2021Updated April 27, 2026

Verified source

U.S. Food and Drug Administration

This summary mirrors the official FDA notice issued August 8, 2021. Last synced from FDA: Apr 27, 2026.

Read official FDA notice

Holle Bio Stage PRE Organic Infant Milk Formula

FDAClass I — Health Riskfood

What's recalled

Holle Bio Stage PRE Organic Infant Milk Formula

Undeclared Allergen Alert

This recall involves undeclared allergens not listed on the label:

milk

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
All codes

Why it was recalled

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

Where was it sold

All sales are direct from firm website - littlebundle.com

nationwide

What to do

  1. Do not consume or use this product
  2. Check the lot numbers or UPC codes listed above
  3. Return the product to the store where you purchased it for a full refund
  4. Contact your healthcare provider if you have experienced any symptoms
View official FDA notice

Common questions about this recall →

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Frequently Asked Questions

Is the Able Groupe Inc recall still active?

Yes, this recall is currently active as of August 8, 2021. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: All codes. Check the label on your product.

What should I do if I have the recalled Able Groupe Inc?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.

Why was Able Groupe Inc recalled in 2021?

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.