FDA recalls Neuroquell Calendula Oil homeopathic drug for manufacturing deviations
The FDA has recalled Neuroquell Calendula Oil, a homeopathic drug, due to manufacturing practice violations. The voluntary recall affected 51 bottles distributed nationwide and in Australia.
What this means for you
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: This is a Class II voluntary recall with no reported illnesses, injuries, or hospitalizations. The hazard is a manufacturing practice deviation, which represents a compliance issue rather than a documented health risk. Per the rubric, voluntary recalls without reported adverse health outcomes are classified as Moderate.
Plain-English summary
Neuroquell, a homeopathic drug containing Calendula Oil packaged in 1/8 fl. oz. (3.5 g) bottles, was voluntarily recalled by Atlantic Management Resources Ltd. The recall affected 51 bottles with lot code B-02, distributed nationwide in the United States and in Australia.
The recall was initiated because the product did not meet current Good Manufacturing Practice (cGMP) standards. The firm initiated the recall on December 12, 2022, and the FDA terminated the recall on September 20, 2023.
Consumers who have this product should follow any instructions provided by the manufacturer. The product is distributed by Claire Ellen Topicals, located in Westborough, MA.
The recalled product
- Product
- Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
- Manufacturer
- Atlantic Management Resources Ltd.
- Category
- Drug — Topical / Homeopathic
- Hazard
- cGMP-deviation
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 Code B-02
Distribution
Distributed nationwide across the United States.
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