HIGH

Neuroquell Recall Issued Over cGMP Violations

Claire Ellen Products recalled 72 containers of Neuroquell and Neuroquell Plus on August 27, 2025. The recall follows violations of current Good Manufacturing Practices (cGMP). Consumers must stop using the products immediately and consult healthcare providers for guidance.

Quick Facts at a Glance

Recall Date
August 27, 2025
Hazard Level
HIGH
Brand
Claire Ellen Products
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

cGMP violations

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Atlantic Management Resources Ltd. or your healthcare provider for guidance. Notification method: E-Mail

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

The recall affects Neuroquell and Neuroquell Plus, 0.22 fl. oz (6.6 mL), manufactured for and distributed by Claire Ellen Products. The affected lot numbers are B-02 Batch #: 1087920520 and Batch # 1087920920.

The Hazard

The recall was initiated due to violations of cGMP. These violations can pose significant health risks to consumers using the product.

Reported Incidents

There are no reported injuries or incidents linked to this recall as of now. The product is classified as a Class II recall.

What to Do

Stop using the recalled products immediately. Contact Atlantic Management Resources Ltd. or consult your healthcare provider for further assistance.

Contact Information

For more information, email Atlantic Management Resources Ltd. or visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0629-2025.

Key Facts

  • Recall date: August 27, 2025
  • Reported date: September 17, 2025
  • 72 containers recalled
  • Manufactured by Claire Ellen Products
  • Distribution via internet

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot # B-02 Batch #: 1087920520
Batch # 1087920920
Report Date
September 17, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

Related Recalls

HIGH

Fresenius Kabi Vancomycin Injection Recalled Over Sterility Concerns

Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Fresenius Kabi Compounding Issues Recall of Vancomycin Injection

Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Pro Numb Tattoo Numbing Spray Recalled Due to cGMP Violations

Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.

PRO NUMB SENSITIVE SKIN
cGMP deviations
Read more