MR — Class I drug recall D-0397-2026
Ongoing recall by StuffbyNainax, reported 2026-03-11. Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalaf
| Recall number | D-0397-2026 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | StuffbyNainax, Huntsville, TX, United States |
| Recall initiated | 2025-12-15 |
| Classified | 2026-03-18 |
| Reported by FDA | 2026-03-11 |
| Quantity | 4 |
| Reason classes | undeclared allergen, unapproved product |
| Expiration dates | 2029-12-31 |
Product
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Reason for recall
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
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-0397-2026. 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.