Neuroquell products recalled over current good manufacturing practice violations
Neuroquell and Neuroquell Plus, 0.22 fl oz, distributed by Claire Ellen Products, are recalled for cGMP violations. 72 containers sold via the internet are affected.
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: Rubric level 2 covers precautionary recalls; the notice cites manufacturing practice violations without describing any defect or health consequence.
Plain-English summary
Neuroquell and Neuroquell Plus, 0.22 fl oz (6.6 mL), manufactured for and distributed by Claire Ellen Products of Westboro, Massachusetts, NDC 66233712-01, are being recalled. Affected codes include lot B-02, batch 1087920520 and batch 1087920920, product number R937, with a best-before date of May 31, 2021. The recall covers 72 containers distributed via the internet.
The recall was issued for current good manufacturing practice violations. The FDA classified the action as Class II. The notice does not describe a specific defect in the product.
Anyone holding this product should stop using it and follow the distributor's instructions for return.
The recalled product
- Product
- Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 66233712-01
- Manufacturer
- Atlantic Management Resources Ltd.
- Category
- Drug — 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 (3)
- Lot # B-02 Batch #: 1087920520 Product # R937 BBE#31-05-21( May 31
- 2021) Batch # 1087920920 Product # R937 BBE# 31-05-21 (May 31
- 2021)
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Atlantic Management Resources Ltd.
See all →- 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
- ModerateHomeopathic Calendula Oil Recalled for Manufacturing Practice Violations
FDA (Drugs) · 2022-12-21
Same hazard · cgmp violation
See all →- Moderatevite20 Antifungal Cream recalled due to stability testing deviations
FDA (Drugs) · 2026-07-08
- ModerateOptim V Anti-Itch Cream Recalled for Current Good Manufacturing Practice Deviations
FDA (Drugs) · 2025-05-28
- ModerateRapidol Hydrocortisone 1% Anti-Itch Cream Recalled for CGMP Deviations
FDA (Drugs) · 2025-05-28
- ModerateNature Mint Anticavity Fluoride Toothpaste Recalled for CGMP Deviations
FDA (Drugs) · 2025-05-28
- ModerateSaxagliptin 5mg Tablets Recalled for Manufacturing Practice Deviations
FDA (Drugs) · 2025-04-16
Similar recalls
- 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
- ModerateMigrenol Caplet Drug Recalled for CGMP Deviations
FDA (Drugs) · 2022-02-16
- ModeratePhenol Topical Solution recalled for CGMP manufacturing deviations
FDA (Drugs) · 2022-02-02
- HighCinacalcet 90 mg tablets recalled over a nitrosamine impurity above limits
FDA (Drugs) · 2025-12-17
- ModeratePhenylephrine HCl 5 mg Tablet Recall Due to CGMP Deviations
FDA (Drugs) · 2022-02-16