Sunset Natural Products Recalls Abee Med Dietary Supplement
Sunset Natural Products is recalling Abee Med dietary supplements under a consent decree requiring the destruction of products manufactured since April 2014.
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 temporary or medically reversible adverse health consequence. The source text does not report specific illnesses or injuries, but the regulatory action (consent decree) indicates a significant compliance failure rather than a minor cosmetic issue.
Plain-English summary
Sunset Natural Products Inc. is recalling Abee Med, a dietary supplement sold in 60-capsule bottles. The recall involves 3,149 bottles (240,000 capsules) distributed in Florida and Nevada. The affected product is identified by Lot # 420415, Exp. Date 04/18, and UPC 850993004017.
This recall is being conducted pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until they recall and destroy the products manufactured or distributed since April 2, 2014. The decree also requires the company to hire a cGMP expert and receive written permission from the FDA to resume operations.
Consumers who purchased Abee Med with the specific lot number and expiration date listed above should stop using the product and follow instructions provided by the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- Abee Med, 60 capsules per bottle. Manufactured by Sunset Natural Products
- Manufacturer
- Sunset Natural Products Inc.
- Category
- Food — Dietary Supplement
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 # 420415 Exp. Date 04/18 UPC 850993004017
Distribution
Part of a larger recall action
This product is one of 10 recalled by Sunset Natural Products Inc. 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.
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