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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Food
Food & Beverages/Baby Food & Formula

Able Groupe Inc: Various Infant Formulas Recalled for Low Iron and Labeling Violations

Agency Publication Date: August 16, 2021
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Summary

Able Groupe Inc. is recalling approximately 1,596,000 units of various HiPP, Holle, Lebenswert, and Kendamil infant formulas sold exclusively through the littlebundle.com website. These products were imported and distributed without the required pre-market notifications to the FDA and lack mandatory English-language labeling and nutritional statements. Several of the formulas contain less than 1 milligram of iron per 100 Calories, which is below the required level for certain infants. Consumers should stop using these formulas and return them to the place of purchase for a full refund.

Risk

Infants who consume these low-iron formulas may not receive enough iron, putting them at risk for iron deficiency and related health issues, especially those who were born prematurely, had low birth weight, or have existing illnesses. Additionally, the lack of English labeling may lead to incorrect preparation or usage, potentially causing nutritional imbalances or other health risks.

What You Should Do

  1. Check your pantry for any of the following brands: HiPP (Comfort, AR, Dutch, HA Germany, German, UK), Holle (Bio, Goat), Lebenswert (Anfangsmilch, Folgemilch), or Kendamil (Organic).
  2. Identify if your product is affected by looking for 'All codes' listed under the product names on your packaging or order history from littlebundle.com.
  3. Immediately stop feeding these recalled formulas to your infant if they are part of this recall.
  4. Return the affected product to the place of purchase (littlebundle.com) for a full refund or contact Able Groupe Inc. for further instructions.
  5. Consult with a healthcare provider or pediatrician if your infant has consumed these products and you have concerns about their iron levels or health.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Full refund for returned products

How to: Return to the place of purchase for a full refund or contact the manufacturer for further instructions

Affected Products

Product: HiPP Comfort Milk Formula
Item Code:
F-0907-2021
Lot Numbers:
All codes
Product: HiPP AR Germany Anti-Reflux Milk Formula
Item Code:
F-0908-2021
Lot Numbers:
All codes
Product: HiPP Dutch Stage 1 Combiotic Infant Milk Formula
Item Code:
F-0909-2021
Lot Numbers:
All codes
Product: HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula
Item Code:
F-0910-2021
Lot Numbers:
All codes
Product: HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula
Item Code:
F-0911-2021
Lot Numbers:
All codes
Product: HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula
Item Code:
F-0912-2021
Lot Numbers:
All codes
Product: HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula
Item Code:
F-0913-2021
Lot Numbers:
All codes
Product: HiPP German Stage 1 Combiotic Infant Milk Formula
Item Code:
F-0914-2021
Lot Numbers:
All codes
Product: HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula
Item Code:
F-0915-2021
Lot Numbers:
All codes
Product: Holle Bio Stage 1 Organic Infant Milk Formula
Item Code:
F-0916-2021
Lot Numbers:
All codes
Product: Holle Bio Stage PRE Organic Infant Milk Formula
Item Code:
F-0917-2021
Lot Numbers:
All codes
Product: Holle Bio Stage 2 Organic Follow-On Infant Milk Formula
Item Code:
F-0918-2021
Lot Numbers:
All codes
Product: Holle Goat Stage 1 Organic Infant Milk Formula
Item Code:
F-0919-2021
Lot Numbers:
All codes
Product: Holle Goat Stage 2 Organic Follow-On Infant Milk Formula
Item Code:
F-0920-2021
Lot Numbers:
All codes
Product: Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula
Item Code:
F-0921-2021
Lot Numbers:
All codes
Product: Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula
Item Code:
F-0922-2021
Lot Numbers:
All codes
Product: Lebenswert Folgemilch Stage 3 Organic Toddler Formula
Item Code:
F-0923-2021
Lot Numbers:
All codes
Product: HiPP UK Stage 1 Combiotic First Infant Milk Formula
Item Code:
F-0924-2021
Lot Numbers:
All codes
Product: HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula
Item Code:
F-0925-2021
Lot Numbers:
All codes
Product: Kendamil Organic Stage 1 First Infant Milk Formula
Item Code:
F-0926-2021
Lot Numbers:
All codes
Product: Kendamil Organic Stage 2 Follow on Milk Formula
Item Code:
F-0927-2021
Lot Numbers:
All codes

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88432
Status: Resolved
Manufacturer: Able Groupe Inc
Sold By: littlebundle.com
Manufactured In: United States
Units Affected: 21 products (76,000 units total)
Distributed To: Nationwide
Agency Last Updated: September 1, 2021

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.