Is Zotrex (ophioglossum polyphyllous) Capsules Dietary Supplement, packaged in 2ct blister packs, 15ct bottles, 30ct bottles, 45ct bottles or sold in bulk, Novacare, LLC, Midvale UT recalled?

Critical RiskFDA Drug

Novacare, LLC: Marketed Without an Approved NDA/ANDA; product contains sulfoaildenafil, an analogue of sildenafil, the active ingredient used in an FDA approved product for the treatment of male erectile dysfunction.; Marketed Without an Approved NDA/ANDA; product may contain sulfoaildenafil, an analogue of sildenafil, the active ingredient used in an FDA approved product for the treatment of male erectile dysfunction.; Marketed Without an Approved NDA/ANDA; product may contain sulfoaildenafil,

Agency Publication Date: January 14, 2011

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 56562

Status: Resolved

Manufacturer: Novacare, LLC

Manufactured In: United States

Units Affected: 19 products (200,166 capsules; 4,009,588 capsules; 2940 capsules; 193,888 capsules; 12,600 capsules; 703 capsules; 198,496 capsules; 190,200 capsules; 10,150 capsules; 124,286 capsules; 35,325 capsules; 31,638 capsules; 296 / 15ct bottles (4440 capsules); 696 / 15ct bottles (10,440 capsdules); None; 20,724 capsules; 2,000 capsules; 4,414 30ct bottles (132,420 capsules); 8,753,847 capsules)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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