The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0082-2023·Announced 2022-12-21

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.

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: 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
Affected units
51

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.

Part of a larger recall action

This product is one of 4 recalled by Atlantic Management Resources Ltd. 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.

See all 4 products in this recall →

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Same manufacturer · Atlantic Management Resources Ltd.

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