HVL Recalls Melatonin Tablets Containing Digestive Enzyme Supplement
HVL, LLC is recalling 278 bottles of Melatonin Control-Released Tablets that contained a vegetarian digestive enzyme instead of melatonin.
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 indicates the product is unlikely to cause adverse health consequences. The hazard is a labeling error where the wrong supplement was packaged, fitting the criteria for minor labeling errors.
Plain-English summary
HVL, LLC is recalling 278 bottles of Melatonin Control-Released Tablets, 60 tablets, in plastic bottles. The product was manufactured by Douglas Laboratories in Pittsburgh, PA. The specific lot number is 50032151, with an expiration date of 12/20/2015.
The recall was initiated because the bottles contained a vegetarian digestive enzyme dietary supplement instead of the labeled melatonin. This is a mislabeling issue where the product contents did not match the label.
The product was distributed nationwide. Consumers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Melatonin Control- Released Tablets, 60 tablets, in plastic bottles, Manufactured by Douglas Laboratories, Pittsburgh, PA.
- Manufacturer
- HVL, LLC
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 278
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 # 50032151
- exp. 12/20/2015
Distribution
Distributed nationwide across the United States.
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