FDA Recall D-0332-2026

HANDELNINE GLOBAL LLC · South Plainfield, NJ

Class I — life-threatening Ongoing 143 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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

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

Quantity: 4 bottles /30 capsules each

Reason for recall

CGMP Deviations: product found to contain lead.

Recall record

Recall number: D-0332-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Product was distributed to one customer in NY.
Recall initiated: 2025-12-22
Classified by FDA Center: 2026-02-12
FDA published: 2026-02-11
Recalling firm: HANDELNINE GLOBAL LLC
Firm location: South Plainfield, NJ

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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