Abbott Recalls Water Bottles Labeled as Similac Pro-Advance Infant Formula
Abbott Nutrition is recalling 111 cases of water-filled bottles incorrectly labeled as Similac Pro-Advance infant formula. The bottles were not intended for distribution.
The agency’s classification
FDA (Food): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric associates with scores of 1 or 2. Given the potential for serious harm if water is mistaken for infant formula, a score of 2 (Moderate) is appropriate for this labeling error.
Plain-English summary
Abbott Nutrition, Division of Abbott Laboratories, is recalling 111 total cases of water-filled bottles that were incorrectly labeled as Similac Pro-Advance Infant Formula with Iron, Milk-Based, Ready to Feed, 32 FL OZ (1 QT). The recall involves Batch Numbers BW3520316 (List Number 64248) and BW0970914 (List Number 66611). The source text notes that no lot or expiration dates are present because the bottles were not intended for distribution.
The products were distributed to Connecticut, Maryland, New Jersey, New York, and Pennsylvania. The recall is classified as FDA Class III, indicating that use or exposure to the violative product is not likely to cause adverse health consequences.
Consumers who possess these items should stop using them and contact Abbott Nutrition for further instructions. The primary issue is the mislabeling of water as infant formula, which poses a risk if the product is consumed by infants.
The recalled product
- Product
- Similac Pro-Advance Infant Formula with Iron, Milk-Based, Ready to Feed, 32 FL OZ (1 QT)
- Category
- Food — Infant Formula
- Hazard
- Affected units
- 111
Distribution
Related recalls
Same manufacturer · Abbott Nutrition, Division of Abbott Laboratories
See all →- ModerateAbbott Recalls Similac Pro-Sensitive Bottles Due to Packaging Error
FDA (Food) · 2019-09-18
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- ModerateSimilac Advance Infant Formula Recalled for Chinese Labeling
FDA (Food) · 2015-03-18
- ModerateAbbott Recalls Similac Pro-Sensitive Bottles Due to Packaging Error
FDA (Food) · 2019-09-18
- CriticalAbbott Similac Pro-Advance Infant Formula Recalled for Bacterial Contamination
FDA (Food) · 2022-03-16
- HighSimilac Alimentum infant formula recalled for packaging defect
FDA (Food) · 2022-09-07
- SevereAbbott Similac infant formula recalled due to bacterial contamination
FDA (Food) · 2022-03-16
- SevereAbbott Similac infant formula recalled for pathogen contamination
FDA (Food) · 2022-03-16