FDA Drug recall D-0003-2025
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A
- FDA Drug
- Class I
- ongoing
- Published 2024-10-09
On 2024-10-09 the FDA classified a Class I recall of Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A by Supercore Products Group, citing marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0003-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-07-12 |
| Published | 2024-10-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Supercore Products Group |
| Distribution | US |
Product
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Reason
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0003-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.