Data Foundry

Drug recalls 2017

ZRECT Male Enhancement Herbal Dietary Supplement Capsules — Class I drug recall D-0963-2017

Terminated recall by Organic Herbal Supply, reported 2017-07-19, distributed nationwide. Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and

Recall numberD-0963-2017
Product typeDrug
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmOrganic Herbal Supply, Roseville, CA, United States
Recall initiated2017-04-18
Classified2017-07-11
Reported by FDA2017-07-19
Terminated2018-03-09
DistributedNationwide (US)
Reason classesundeclared allergen, unapproved product
UPC / GTIN / UDI-DI00852675999451

Product

ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 852675999451

Reason for recall

Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0963-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.