RecallHawk
Class I Recall

Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313

HANDELNINE GLOBAL LLC

Summary

The FDA issued a Class I for Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd by HANDELNINE GLOBAL LLC. Reason: CGMP Deviations: product found to contain lead..

Details

Source

Drug Recall

External ID

D-0332-2026

Action Date

2026-02-11

Status

Ongoing

Category

drug

Product Description

Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313

Lot/Code Info: Lot: CAM040, Exp. 06/30/2029 Lot: CAL079-N, Exp. 09/30/2028

Quantity Affected: 4 bottles /30 capsules each

Reason for Recall

CGMP Deviations: product found to contain lead.

Distribution

Product was distributed to one customer in NY.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-12-22

Company

HANDELNINE GLOBAL LLC

South Plainfield, NJ

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (HANDELNINE GLOBAL LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does HANDELNINE GLOBAL LLC have FDA actions?

This is the only FDA action we have on record for HANDELNINE GLOBAL LLC in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "D-0332-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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