Dietary Supplements Recalled for Undeclared Soy Allergen
Provident Nutraceutical is recalling 95 bottles of various branded dietary supplements because they may contain undeclared soy.
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 High severity score per the rubric.
Plain-English summary
Provident Nutraceutical, a division of Ortho Molecular Products Inc, is recalling 95 bottles of dietary supplements. The products are 60-capsule bottles with UPC 15033-61832 and Product # 832060, packaged in white plastic bottles with black plastic lids. The recall is due to the potential presence of undeclared soy in the supplements.
The affected products are labeled under several brands, including Aspire Rejuvenation Nutraceuticals (Tranquility PM), Living Well Clinical Nutrition Center (SleepForce), Swiss Rx (Nighttime), Energy Health (Neuro Calm PM), Nutra Molecular (Nutra Calm PM), Good Medicine (NeuroSleep), and WiseMeds (Tranquil PM + GABA). The specific lot number is 83659F with an expiration date of 09/30/2021.
The products were distributed in California, Florida, Ohio, Texas, and Washington. Consumers who have purchased these products should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- Dietary supplements, 60 capsules, UPC 15033-61832, Product # 832060, labeled under the following brands and product names, packaged in white plastic bottle with black plastic lid: 1. Aspire Rejuvenation Nutraceuticals, Tranquility PM, Mfg for: Aspire Rejuvenation…
- Category
- Food — Dietary Supplements
- Hazard
- Affected units
- 95
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 83659F EXP 09/30/2021
Distribution
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