The Recall Desk
ModerateFDA (Drugs)·D-0084-2023·Announced 2022-12-21

Homeopathic Calendula Oil Recalled for Manufacturing Practice Violations

Atlantic Management Resources voluntarily recalls Menastil homeopathic calendula oil due to cGMP deviations. The 26 bottles (Lot A-01) were distributed nationwide and to 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 recall for manufacturing practice deviations with no reported illnesses, injuries, or hospitalization. The source text indicates no actual harm, making this a voluntary precautionary recall for a quality control issue.

Plain-English summary

Atlantic Management Resources Ltd. has voluntarily recalled Menastil, A Homeopathic Formula, Calendula Oil, packaged in 1/8 fl. oz. (3.5 g) bottles. The recall affects 26 bottles with lot code A-01, manufactured for and distributed by Claire Ellen Topicals in Westborough, Massachusetts.

The recall was initiated due to deviations from current Good Manufacturing Practice (cGMP) standards. No illnesses or injuries have been reported in association with this product.

The product was distributed nationwide in the United States and to Australia. Consumers who have purchased this product should discontinue use and contact the manufacturer for guidance on return or disposal.

The recalled product

Product
Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.
Manufacturer
Atlantic Management Resources Ltd.
Hazard
  • gmp-deviation
  • manufacturing-practice

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 A-01

Distribution

Distributed nationwide across the United States.