On January 10, 2026, Handelnine Global Limited, operating under the trade name Navafresh, announced a nationwide recall of their Rheumacare Capsules, manufactured by Virgo UAP Pharma Pvt. Ltd. (Virgo). This decision comes after tests conducted by the U.S. Food and Drug Administration (FDA) identified lead contamination levels as high as 11,100 ppm, which far exceed permissible safety limits. Regulatory and clinical professionals, as well as affected customers, are encouraged to pay close attention to this recall due to its significant health implications.
Key points:
- The recall affects Rheumacare Capsules with lot numbers CAM040 and CALO79-N.
- Lead exposure at elevated levels can cause cognitive, reproductive, and neurological health risks.
- Consumers are urged to stop using and discard the affected products immediately.
- A refund is available for previously purchased lots.
- This recall has been initiated with FDA oversight.
In this article:
- Why was the recall initiated?
- What are the health risks of lead exposure?
- What steps should consumers take?
- Frequently Asked Questions
- Conclusion and implications
- Disclaimer for professionals
- FDA announcement link
Why was the recall initiated?
Handelnine Global Limited voluntarily issued the recall after FDA testing on Rheumacare Capsules revealed alarmingly high lead concentrations of up to 11,100 ppm. This level is considered intolerable and poses risks to public health. The product, aimed at easing joint pain, was distributed nationwide through Navafresh’s website. To date, one adverse event linked to the product has been reported.
What are the health risks of lead exposure?
Lead is a toxic heavy metal, and prolonged exposure can lead to serious health consequences, including:
- Cognitive impairment: Difficulties with memory, attention, and learning.
- Neurological issues: Symptoms such as motor incoordination and peripheral neuropathy.
- Digestive disorders: Nausea, vomiting, abdominal pain, and constipation.
- Reproductive effects: Increased miscarriage risk in women and reduced fertility in men.
- Severe toxicity: Risks of seizures, coma, or death in cases of acute lead poisoning.
Consumers who have taken the affected product should monitor their health and consult medical professionals for advice and evaluation. Anemia and heightened depression or anxiety are also associated with chronic lead exposure.
What steps should consumers take?
Handelnine Global Limited is notifying all distributors and customers by email of the recall. Affected customers should:
- Cease usage of Rheumacare Capsules immediately.
- Dispose of affected product from lot numbers CAM040 and CALO79-N properly.
- Request a refund from Handelnine Global Limited if they purchased the product through Navafresh.
Consumers seeking further guidance can contact Mr. Ankit Mota via phone at +1 442-223-0999 or email legal@handelnine.com. Operating hours are Monday to Friday, 10 am to 5 pm GMT.
Frequently Asked Questions
- Is the product safe if I continue using it? No, the product poses health risks due to its elevated lead levels and should not be consumed.
- How can I confirm if my capsules are affected? Check for lot numbers CAM040 and CALO79-N on the container label.
- Will refunds cover shipping costs? Refunds pertain to product costs only, and customers are advised to confirm details with the company.
- Can I report adverse reactions? Yes, adverse reactions can be reported to the FDA via their MedWatch Adverse Event Reporting program (online link).
Conclusion and implications
This recall underscores the importance of rigorous quality testing and the adverse effects of lead contamination. Regulatory teams must remain vigilant to prevent similar incidents, while healthcare professionals should guide affected individuals. Consumers should act swiftly to avoid health risks and secure refunds for impacted purchases.
Disclaimer for professionals
The information in this article is provided for awareness purposes within regulatory and clinical fields and does not constitute legal advice. Professionals should consult appropriate legal or medical resources for specific concerns.
FDA announcement link
For full information about the FDA announcement, see the link below.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/handelnine-global-limited-dba-navafresh-issues-nationwide-recall-rheumacare-capsules-virgo-uap