Pro Bioteks Bio-35 Supplement Recalled for Undeclared Soy Lecithin
Pro Bioteks Laboratories is recalling Bio-35 dietary supplements because they contain undeclared soy lecithin, a common allergen.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves allergen mislabeling on a common allergen (soy), which corresponds to a severity score of 3 per the rubric.
Plain-English summary
Pro Bioteks Laboratories is voluntarily recalling approximately 600,000 soft gel capsules of Bio-35, Vitamin-Mineral Omega Oils Trace Minerals Dietary Supplement. The recall is due to the presence of undeclared soy lecithin in the product.
The affected product is identified by Lot # 2037055 and an expiration date of 06/12/2020. The product was distributed nationwide to Arizona, California, Colorado, Florida, Idaho, Louisiana, Minnesota, Missouri, New Mexico, Nevada, Oregon, Texas, Utah, Washington, and Wyoming. There are no foreign, VA, government, or military consignees.
Consumers with this product should stop using it and contact Pro Bioteks Laboratories for a refund or further instructions. Individuals with a soy allergy should be particularly cautious, as the undeclared ingredient poses a risk of allergic reaction.
The recalled product
- Product
- Bio35, Vitamin-Mineral Omega Oils Trace Minerals Dietary Supplement, 100 Softgel Capsules. UPC 0-26341-12900-2
- Manufacturer
- Pro Bioteks Laboratories
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 600,000
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# 2037055 Exp 06/12/2020
Distribution
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