GnuPharma Sleep Herbal Supplement Recalled for E. coli Contamination
GnuPharma Corp. is recalling GnuPharma Sleep 100% Herbal Supplement because one ingredient failed identity testing and two failed microbiological testing for E. coli.
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 a high-risk pathogen (E. coli) without reported illness, which meets the criteria for a High severity score under the rubric.
Plain-English summary
GnuPharma Corp. is voluntarily recalling GnuPharma Sleep 100% Herbal Supplement, 60 capsules. The recall affects products manufactured prior to May 8, 2017, and distributed in the United States.
The recall was initiated because one ingredient failed identity testing and two ingredients failed microbiological testing for Escherichia coli (E. coli). The source text does not specify the number of affected units or report any illnesses or injuries.
Consumers who have purchased this product should stop using it and contact GnuPharma Corp. for further instructions or a refund.
The recalled product
- Product
- GnuPharma Sleep 100% Herbal Supplement 60 Capsules
- Manufacturer
- GnuPharma Corp.
- Category
- Food — Dietary Supplement
- Affected units
- 1
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)
- products manufactured prior to May 8th
- 2017.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by GnuPharma Corp. 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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