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Able Groupe Inc
FDA recall F-0925-2021 · Class II · reported 2021-08-25 · Terminated
- Product
- HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula
- 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.
- Quantity
- 76,000 units total
- Distribution
- All sales are direct from firm website - littlebundle.com
- Firm location
- NV, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Recall started
- 2021-08-08
- Terminated
- 2021-09-08
- Code info
- All codes
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.