Data Foundry

Drug recalls 2023

DYNAMITE SUPER capsule — Class I drug recall D-0573-2023

Ongoing recall by Gadget Island, Inc, reported 2023-05-10, distributed nationwide. Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and

Recall numberD-0573-2023
Product typeDrug
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmGadget Island, Inc, West Sacramento, CA, United States
Recall initiated2023-04-26
Classified2023-05-11
Reported by FDA2023-05-10
DistributedNationwide (US)
Quantity140 blister
Reason classesundeclared allergen, unapproved product
UPC / GTIN / UDI-DI00675799376027
Lot numbersOMS760-B
Model numbersOMS760-B
Expiration dates2025-12

Product

DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.

Reason for recall

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

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-0573-2023. 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.