The Recall Desk
ModerateFDA (Drugs)·D-0083-2023·Announced 2022-12-21

Drug Recall: ProSirona Homeopathic Calendula Oil Manufacturing Deviations

ProSirona Homeopathic Calendula Oil (Lot B-02) is being recalled because the manufacturer failed to follow Current Good Manufacturing Practice standards. The voluntary recall affects products 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 an FDA Class II voluntary precautionary recall due to manufacturing practice deviations with no reported illnesses or injuries. Per the severity rubric, manufacturing compliance issues without specific confirmed hazards or health impacts are classified as Moderate.

Plain-English summary

ProSirona, a homeopathic formula calendula oil packaged in 1/8 fl. oz. bottles, is the subject of this FDA recall. The product was distributed nationwide and to Australia under Lot Code B-02, with 72 bottles recalled.

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations—violations of FDA manufacturing standards. This voluntary recall was initiated by the recalling firm, Atlantic Management Resources Ltd., on December 12, 2022, and was terminated on September 20, 2023.

Consumers who have purchased this product should discontinue use immediately. No illnesses or injuries have been reported in connection with this recall. For more information or to report any adverse events, consumers may contact the FDA or the recalling firm.

The recalled product

Product
ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.
Manufacturer
Atlantic Management Resources Ltd.
Category
Drug — Homeopathic / Topical
Hazard
Affected units
72

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 →

Related recalls

Same manufacturer · Atlantic Management Resources Ltd.

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Same hazard · manufacturing deviation

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