National Vitamin Recalls Ferrous Gluconate Tablets Due to Mislabeled Iron Content
National Vitamin Co Inc is recalling Nature's Blend Ferrous Gluconate Tablets because the front panel incorrectly lists 65 mg of elemental iron instead of the correct 36 mg.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II and involves a labeling error regarding iron content. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported illness or injury fall under the Moderate severity category.
Plain-English summary
National Vitamin Co Inc is voluntarily recalling Nature's Blend Ferrous Gluconate Tablets, 5gr (325 mg), 100 Tablets. The recall is due to a labeling error on the front panel of the bottle, which states that the tablets contain 65 mg of elemental iron. The correct amount of elemental iron per tablet is 36 mg, as indicated on the side panel and the tablets themselves.
The affected product is identified by Lot No. 3KB01 and 3LB72 and UPC 0 79854 50032 5. A total of 13,240 units were distributed nationwide in the US. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.
Consumers who have purchased these specific lots of Nature's Blend Ferrous Gluconate Tablets should stop using them and contact National Vitamin Co Inc for a refund or further instructions. The discrepancy in labeling could lead to confusion regarding the actual iron dosage, although the physical tablets contain the correct amount of 36 mg elemental iron.
The recalled product
- Product
- Ferrous Gluconate Tablets, 5gr (325 mg), Elemental Iron 36 mg, 100 Tablets, UPC 0 79854 50032 5
- Manufacturer
- National Vitamin Co Inc
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 13,240
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)
- Lot No. 3KB01 and 3LB72
Distribution
Distributed nationwide across the United States.
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