Skip to main content
FoodRecallWatch
Class II, May Cause HarmF-0912-2021

HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula

Recalled by Able Groupe INC on Aug 8, 2021

Reviewed by FoodRecallWatch Editorial Team · Updated

Recall Summary

Able Groupe INC recalled HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula in a Class II action, the FDA tier for products that may cause temporary or medically reversible health effects on Aug 8, 2021.

The FDA-published reason for this recall is: "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."

Distribution was limited; the FDA record lists "All sales are direct from firm website - littlebundle.com." Single-area recalls still warrant a kitchen check for anyone who shops within that footprint. The recalling firm is based in Sparks, NV. The recall covers 76,000 units total of product. The FDA has Terminated this recall (first reported Aug 25, 2021), its final lifecycle state, indicating the agency considers the corrective action resolved. The historical record remains useful for tracking a brand's recall pattern over time.

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 Description

HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula

Distribution

All sales are direct from firm website - littlebundle.com

What Should You Do?

  • 1.Check your kitchen for this product immediately.
  • 2.Do not consume the recalled product.
  • 3.Return the product to where you bought it for a full refund, or throw it away.
  • 4.If you have experienced any health issues, contact your healthcare provider.

Browse Related Recalls

Terms Explained

Source: FDA Recalls, Market Withdrawals and Safety Alerts, 2026.