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Navafresh Recalls Rheumacare Capsules Due to Elevated Lead Levels

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Filed December 22nd, 2025
Detected March 12th, 2026
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Summary

Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Rheumacare Capsules due to elevated lead levels found by the FDA. The recall impacts consumers nationwide and is being conducted with the FDA's knowledge.

What changed

Handelnine Global Limited, doing business as Navafresh, is initiating a nationwide recall of Rheumacare Capsules (Lot Numbers CAM040 & CALO79-N) after FDA testing revealed lead levels up to 11,100 ppm, significantly exceeding permissible limits. The company is recalling the product to the consumer level due to the potential public health risks associated with sustained exposure to elevated lead, including neurological and reproductive health issues. One adverse event complaint has been reported.

Consumers who have purchased the affected Rheumacare Capsules are instructed to stop using and discard the product immediately. Navafresh will issue refunds for affected orders. Consumers experiencing any health issues related to the product should consult their physician and are encouraged to report adverse events to the FDA's MedWatch program. The company is notifying distributors and customers via email.

What to do next

  1. Consumers should stop using and discard Rheumacare Capsules Lot Numbers CAM040 & CALO79-N.
  2. Consumers should contact their physician if they have experienced any health problems related to the product.
  3. Consumers should report adverse events to the FDA's MedWatch program.

Source document (simplified)

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Summary

Company Announcement Date:

December 22, 2025

FDA Publish Date:

December 22, 2025

Product Type: Drugs Reason for Announcement: Recall Reason Description Elevated levels of lead Company Name: Handelnine Global Limited d/b/a Navafresh Brand Name: Brand Name(s) Virgo Product Description: Product Description Rheumacare Capsules

Company Announcement

Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Lot Numbers CAM040 & CALO79-N of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo) to the consumer level. In test conducted by the Food and Drug Administration the product has been found to contain lead at levels up to 11,100 ppm, which are higher than permissible levels.

Risk Statement: The product potentially could result in public health risk. Sustained exposure of elevated levels of lead poses increased potential toxicological risks to consumers to include cognitive impairment, depression, nausea and abdominal pain, motor incoordination, and peripheral neuropathy (loss of muscle control). Prolonged exposure has also been linked to the development of anemia. From a reproductive health standpoint, chronic lead exposure has been correlated with increased risk of miscarriage in females and reduced fertility in males. Acute toxicity of lead poisoning could lead to abdominal pain/colic, vomiting, constipation, peripheral neuropathy, and cerebral edema and encephalopathy, which can lead to seizures, coma, and death. To date, Handelnine Global Limited has received one adverse event complaint related to this recall.

The product is used to reduce joint pain and is packaged in white plastic containers bearing the label of the brand Rheumacare Capsules. The affected Rheumacare Capsules lots include the following CAM040 & CALO79-N. Product was distributed nationwide via our website www.navafresh.com.

Handelnine Global Limited is notifying its distributors and customers by email of the recalled product. Consumers that have product which is being recalled should stop using and discard the product immediately. A refund shall be issued to consumers who had placed orders for the product with us.

Consumers with questions regarding this recall can contact Mr. Ankit Mota at Handelnine Global Limited by phone number +1 442-223-0999 or e-mail address legal@handelnine.com on Monday to Friday from 10 am to 5 pm, GMT (UK time). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company Contact Information

Consumers: Mr. Ankit Mota, Handelnine Global Limited +1 442-223-0999 legal@handelnine.com

Product Photos

  • Content current as of:

12/22/2025

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
Food and Drug Administration
Filed
December 22nd, 2025
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Consumers Drug manufacturers
Geographic scope
National (US)

Taxonomy

Primary area
Food Safety
Operational domain
Compliance
Topics
Drug Recalls Consumer Safety

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