Elroselabs Recalls Molleave OTC Product Due to cGMP Deviations
Elroselabs Inc. is voluntarily recalling Molleave, 2 oz bottles, due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed nationwide.
The agency’s classification
FDA (Drugs): 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 and is voluntary. The source text does not report any illnesses, injuries, or deaths, and the hazard is related to manufacturing deviations rather than a specific high-risk pathogen or structural defect, fitting the criteria for a moderate severity score.
Plain-English summary
Elroselabs Inc. is voluntarily recalling Molleave, 2 oz bottles, an over-the-counter (OTC) product. The recall was initiated on March 28, 2018, and was classified as Class II by the U.S. Food and Drug Administration. The reason for the recall is cited as current Good Manufacturing Practice (cGMP) deviations.
The affected product was distributed nationwide. The recall status is currently terminated, with a termination date of December 15, 2020. The initial firm notification to consumers was via letter.
Consumers with this product should follow the instructions provided in the notification letter or contact the recalling firm for further information. No specific lot numbers or expiration dates are listed in the source text, other than the general code information "All product within expiry."
The recalled product
- Product
- Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc.
- Manufacturer
- Elroselabs Inc.
- Category
- Drug — Over-the-Counter (OTC)
- Hazard
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)
- All product within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Elroselabs Inc. under a single FDA (Drugs) 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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