21st Century Vitamin D3 Tablets Recalled for Incorrect Labeling
Twenty-First Century Healthcare is recalling 21st Century Vitamin D3 tablets because some bottles were mislabeled with a lower dosage.
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, which typically involves a minor labeling error or low-risk contamination. The hazard is limited to incorrect dosage labeling on the primary label, while the secondary label remains correct.
Plain-English summary
Twenty-First Century Healthcare, Inc. is recalling a small quantity of 21st Century Vitamin D3 125 mcg (5000 IU) tablets, 100 count. The recall is due to a labeling error where some bottles were mislabeled as Vitamin D3 25 mcg (1000 IU). The secondary labeling on the back of the bottles is correctly labeled as Vitamin D3 125 mcg (5000 IU).
The affected product is identified by Lot 15769204 and expiration date 01/24. The product was distributed in Arizona. A total of 22,560 bottles were distributed, with 2,425 bottles identified with the incorrect label.
Consumers should check their bottles for the specific lot and expiration date. If the product matches the description, consumers should stop using it and contact the manufacturer for a refund or replacement.
The recalled product
- Product
- 21st Century Vitamin D3 125 mcg (5000 IU) tablet, 100 count, UPC 7-40985-27431-6, 21st Century HealthCare, Inc., 2119 Wilson St., Tempe, AZ 85282
- Manufacturer
- Twenty-First Century Healthcare, Inc
- Category
- Drug — Vitamins and Supplements
- Hazard
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: 15769204
- Exp.: 01/24 020821 0805 through 020821 0838
Distribution
Distributed in 1 state:
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