MR. 7 SUPER 700000 capsules recall
FDA recall D-0397-2026 · initiated Dec 15, 2025
StuffbyNainax recalled MR. 7 SUPER 700000 capsules in Dec 2025 — an FDA Class I recall (D-0397-2026) because Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Sold unapproved, or found to contain something undeclared
The product should not have been on sale in this form — often a supplement found to contain a hidden prescription drug.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4
Details
- Product
- MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
- Recalling company
- StuffbyNainax
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed to 4 customers in the US.
- Initiated
- Dec 15, 2025
- FDA report date
- Mar 11, 2026
Frequently asked
- Was MR. 7 SUPER 700000 capsules recalled?
- StuffbyNainax recalled MR. 7 SUPER 700000 capsules in Dec 2025 — an FDA Class I recall (D-0397-2026) because Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was MR. 7 SUPER 700000 capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0397-2026 was: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
- Is a recalled MR. 7 SUPER 700000 capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of MR. 7 SUPER 700000 capsules are affected?
- Distributed: Product was distributed to 4 customers in the US.. The recall covers these lots — All codes; Exp 12/31/2029. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0397-2026.