Spanish Fly 22K capsules recall
FDA recall D-0448-2024 · initiated Mar 19, 2024
Pyramids Wholesale Inc. recalled Spanish Fly 22K capsules in Mar 2024 — an FDA Class I recall (D-0448-2024) because Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or 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: 45 boxes
Details
- Product
- Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
- Recalling company
- Pyramids Wholesale Inc.
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Mar 19, 2024
- FDA report date
- May 1, 2024
Frequently asked
- Was Spanish Fly 22K capsules recalled?
- Pyramids Wholesale Inc. recalled Spanish Fly 22K capsules in Mar 2024 — an FDA Class I recall (D-0448-2024) because Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Spanish Fly 22K capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0448-2024 was: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Is a recalled Spanish Fly 22K 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 Spanish Fly 22K capsules are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — All lots. 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-0448-2024.