The Recall Desk
SevereFDA (Food)·F-0916-2021·Announced 2021-08-25

Holle Bio Stage 1 Organic Infant Formula Recall for Inadequate Iron Content and Labeling

Able Groupe Inc is recalling Holle Bio Stage 1 Organic Infant Milk Formula because the product may contain insufficient iron for some infants and lacks required FDA labeling statements. The recall affects approximately 76,000 units sold directly through littlebundle.com.

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: This recall is classified as FDA Class I by the issuing agency, which requires a minimum severity score of 4. Although no reported illnesses or injuries are stated, the hazard involves potential nutritional inadequacy in infant formula—a high-risk population product—combined with failure to submit pre-market notifications and missing mandatory labeling.

Plain-English summary

Able Groupe Inc is recalling all units of Holle Bio Stage 1 Organic Infant Milk Formula sold through its website littlebundle.com. The FDA has classified this as a Class I recall.

The company did not submit required pre-market notifications to the FDA for these infant formulas. Some products contain less than 1 milligram of iron per 100 Calories, which may not provide adequate iron for certain infants, including those born prematurely, with low birth weight, with low iron levels at birth, or at risk for iron deficiency due to illness. Additionally, the products are not labeled as required by FDA regulations 21 CFR 107.10 and 107.20 and do not include mandatory labeling statements in English.

Approximately 76,000 units have been distributed. Consumers who have purchased this product should consult their healthcare provider. The company is conducting this recall at the FDA's request.

The recalled product

Product
Holle Bio Stage 1 Organic Infant Milk Formula
Manufacturer
Able Groupe Inc
Category
Food — Infant Formula
Hazard
  • inadequate-iron
  • missing-labeling
  • pre-market-notification-failure

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.

Related recalls

Same category