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.
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 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.
- Category
- Drug — Homeopathic
- Affected units
- 26
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.
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.
See all →- ModerateNeuroquell products recalled over current good manufacturing practice violations
FDA (Drugs) · 2025-09-17
- ModerateDrug Neuroquell Plus Calendula Oil Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-12-21
- ModerateFDA recalls Neuroquell Calendula Oil homeopathic drug for manufacturing deviations
FDA (Drugs) · 2022-12-21
- ModerateDrug Recall: ProSirona Homeopathic Calendula Oil Manufacturing Deviations
FDA (Drugs) · 2022-12-21
Same hazard · gmp deviation
See all →- HighPrazosin hydrochloride tablets recalled over nitrosamine impurity above limits
FDA (Drugs) · 2026-04-08
- HighPrazosin hydrochloride further lots recalled over nitrosamine impurity levels
FDA (Drugs) · 2026-04-08
- HighPrazosin hydrochloride 100-count bottles recalled over nitrosamine impurity
FDA (Drugs) · 2026-04-08
- ModerateFirst Aid Only hand sanitizing wipes recalled over manufacturing deviations
FDA (Drugs) · 2026-03-11
- ModerateFirst Aid Only BZK antiseptic towelettes recalled over manufacturing deviations
FDA (Drugs) · 2026-03-11
Similar recalls
- ModerateGood Herbs Calendula Recalled for GMP Violations
FDA (Food) · 2014-11-05
- ModerateMenthol pain relief gel recalled over manufacturing practice deviations
FDA (Drugs) · 2025-12-03
- HighDrug Recall: Alprostadil Affected by Manufacturing Practice Deviations
FDA (Drugs) · 2025-03-19
- ModerateMedisca Recalls Estradiol Bulk Due to cGMP Deviations
FDA (Drugs) · 2017-04-19
- ModerateHerbal Doctor Remedies Recalls Appetrol Capsules for CGMP Deviations
FDA (Drugs) · 2019-08-14
- ModerateMedisca Recalls Estradiol API Due to cGMP Deviations
FDA (Drugs) · 2017-04-19