The Recall Desk
SevereFDA (Food)·F-0923-2021·Announced 2021-08-25

Lebenswert Folgemilch Stage 3 Organic Toddler Formula Recalled

Able Groupe Inc is recalling Lebenswert Folgemilch Stage 3 Organic Toddler Formula because required FDA pre-market notifications were not submitted and the product lacks mandatory labeling in English as required by federal regulations.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall. The product is an infant formula that lacks required pre-market FDA notification and mandatory labeling, creating potential health and safety risks for vulnerable infants who depend on proper formula labeling for safe preparation and use.

Plain-English summary

Able Groupe Inc is recalling Lebenswert Folgemilch Stage 3 Organic Toddler Formula, a product distributed exclusively through the firm's website at littlebundle.com. The recall affects all units of this product.

The recall was initiated because the required pre-market notifications for this infant formula have not been submitted to the FDA. Additionally, the product is not labeled as required by 21 CFR 107.10 and 107.20 and does not bear mandatory labeling statements in English.

Consumers who have purchased this product should be aware that it does not comply with federal labeling requirements for infant formula. For more information or to report adverse effects, consumers should contact the FDA through its official safety and recalls website.

The recalled product

Product
Lebenswert Folgemilch Stage 3 Organic Toddler Formula
Manufacturer
Able Groupe Inc
Hazard
  • missing-pre-market-notification
  • inadequate-labeling
  • missing-english-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All codes

Distribution

Distribution scope not specified by the agency.