Wellements Iron Drops Recalled for Undeclared Milk Allergen
Wellements LLC is recalling Iron Drops liquid dietary supplements because they contain undeclared milk. Consumers with milk allergies should not use the product.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric. Additionally, undeclared milk is a high-risk allergen mislabeling.
Plain-English summary
Wellements LLC is voluntarily recalling 27,557 bottles of Iron Drops (UPC 729609000098) liquid dietary supplements. The product is a 1 oz/30 mL amber glass bottle packaged in a carton with a 1 mL oral syringe dispenser. The recall is being conducted because the product contains undeclared milk, a major food allergen.
The affected products are identified by Lot 18491 BB 1/2021 and Lot 10592 BB 10/2020. These items were distributed nationwide to the following states: Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Massachusetts, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin.
Consumers with a milk allergy or sensitivity should not use the recalled product. Individuals who have already consumed the product and are experiencing symptoms should contact a healthcare provider. Consumers may contact Wellements LLC for more information or to return the product.
The recalled product
- Product
- Iron Drops (UPC 729609000098) liquid Dietary Supplement, 1 oz/30 mL amber glass bottle packaged in an individual product carton that includes a 1 mL oral syringe dispenser.
- Manufacturer
- Wellements LLC
- Category
- Food — Dietary Supplement
- Affected units
- 27,557
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 (2)
- Lot 18491 BB 1/2021
- Lot 10592 BB 10/2020
Distribution
Part of a larger recall action
This product is one of 2 recalled by Wellements LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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