Able Groupe Inc 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.

🇺🇸 United States

1. August 8, 2021 - Recall initiated
2. August 25, 2021 - Reported by source
3. September 8, 2021 - Recall terminated

Official source record

Agency

FDA

Dataset

FDA Food Enforcement (Recalls)

Recall number

F-0915-2021

Event ID

88432

Status

Terminated

Classification

Class II

Company

Able Groupe Inc

Product description

HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula

Quantity

76,000 units total

Reason

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.

Recall initiation date

August 8, 2021

Report date

August 25, 2021

Classification date

Not published in this source record

Termination date

September 8, 2021

Distribution pattern

All sales are direct from firm website - littlebundle.com

UPC, lot, and code information

All codes

Voluntary or mandated

Voluntary: Firm initiated

Initial notification method

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Source last updated

Not tracked separately from the Public Health Trace retrieval date below

Public Health Trace retrieval date

July 18, 2026 ET

Other products recalled under this same event

This recall shares FDA event ID 88432 with 10 other product entries in Public Health Trace.

Responsible company: Able Groupe Inc

Other recalls from Able Groupe Inc

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace: July 18, 2026 ET

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.

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