Hard Steel Capsules packaged in 1 count blister packs in boxes of 10 — Class I drug recall D-0003-2025
Ongoing recall by Supercore Products Group Inc., reported 2024-10-09, distributed nationwide. Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen
| Recall number | D-0003-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Supercore Products Group Inc., Atlanta, GA, United States |
| Recall initiated | 2024-07-12 |
| Classified | 2024-10-02 |
| Reported by FDA | 2024-10-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, GB, IL, MA, PK |
| Quantity | 729 |
| Reason classes | undeclared allergen, unapproved product |
Product
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Reason for recall
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
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-0003-2025. 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.