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RECALL RECORD — CLASS IIRecall closedF-0911-2021/FDA enforcement
Able Groupe INC·Food·Aug 8, 2021

Hipp Dutch Stage 2 Combiotic Follow-on Milk Formula

What you need to know

Class II

  • What happened

    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…

  • Health risk

    The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. A safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.

  • Action required

    Check the identifying codes below and stop using the product. Return it to the retailer for a refund or dispose of it safely, following the recall notice.

Recall closed · classified by the FDADistribution not listedMore food

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Match before you discard

Product identification

Source: FDA FOOD

Brand nameAble Groupe INC
Recalling firmAble Groupe INCSparks, NV, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • All codes
Distribution area

All sales are direct from firm website - littlebundle.com

United States

Quantity affected76, 000 units total
Recall initiationFDA report date: August 25, 2021
FDA recall numberF-0911-2021

Beyond the headline

The recall, in context

Able Groupe INC initiated this food recall on August 8, 2021. The FDA enforcement report states: 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. The FDA report lists distribution as: All sales are direct from firm website - littlebundle.com.

The FDA enforcement report describes the reason as: 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.

Hipp Dutch Stage 2 Combiotic Follow-on Milk Formula was made or distributed by Able Groupe INC in Sparks, NV, United States. This page reflects FDA report F-0911-2021, dated August 25, 2021.

Why this is a Class II recall

Class II means the product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. In this recall, a safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.

FDA definition

The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote.

What to do now

  1. 1

    Stop using it

    Do not eat, drink or take the affected product.

  2. 2

    Check the codes

    Compare the lot and date codes against the table above.

  3. 3

    Return or discard

    Contact the retailer or recalling firm about a refund, and dispose of the product safely.

Consumer safety guide

Product safety recall

Symptoms to watch for

The official enforcement report describes the specific risk. Follow the recall notice, check the product codes and do not use a product that may be affected.

Higher-risk groups

Children, pregnant people, older adults and people with weakened immune systems should take extra care when a product's safety is uncertain.

What to do now

  1. 1Stop using or eating the product and keep it away from children and pets.
  2. 2Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return.
  3. 3Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Read the official source record for the specific hazard and instructions.

This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.

Frequently asked

Questions about this recall

What is the Hipp Dutch Stage 2 Combiotic Follow-on Milk Formula recall?

Able Groupe INC recalled Hipp Dutch Stage 2 Combiotic Follow-on Milk Formula in an FDA Class II enforcement action reported as F-0911-2021. 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…

What should I do if I bought this product?

Check the identifying codes below and stop using the product. Return it to the retailer for a refund or dispose of it safely, following the recall notice. Stop using or eating the product and keep it away from children and pets. Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return. Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Is the Able Groupe INC recall still active?

The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record F-0911-2021. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.

Verify before you act.

VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.

Official source

Brand history

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Record last synced from official openFDA enforcement data on November 14, 2026. Source record: official FDA notice.