A supplement containing the prescription drug tadalafil - the only such record among 1,408 (AKKARCO)
The U.S. FDA classified as Class I a recall of Ashfiat Alharamain Energy Support, 250 ml, sold by AKKARCO. The reason is undeclared tadalafil, an ingredient of prescription medicines.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeFood
- Recalling firmAKKARCO LLC
- ReasonUndeclared tadalafil
- DistributionThe product was distributed nationwide through third-party e-commerce marketplace: Amazon.com
- Recall initiated2026-01-28
Key points
- The product is Ashfiat Alharamain Energy Support, 250 ml, totalling 1,052 units, classified Class I.
- The reason is undeclared tadalafil, an ingredient of prescription medicines for erectile dysfunction.
- Tadalafil can lower blood pressure to dangerous levels when combined with nitrates.
- Distribution was nationwide through a third-party e-commerce marketplace, so removing it from a shelf does not complete the recall.
- Of the 1,408 FDA recall records this site holds as of 2026-09-02, this is the only one citing tadalafil or sildenafil.
- Most of the 105 records citing an undeclared ingredient concern food allergens; an undeclared drug ingredient is different in kind.
1A prescription ingredient inside a dietary supplement
Dietary supplements are sold in a category that does not require pre-market approval, unlike medicines. Where a product in that category contains a prescription drug ingredient without declaring it, the buyer has no way of knowing what they are taking.
Tadalafil is an ingredient used for erectile dysfunction and can lower blood pressure to dangerous levels when combined with nitrates, which are prescribed for angina among other conditions. Someone taking nitrates for a heart condition consuming this as a supplement is the concern here.
2What it means that the channel is an online marketplace
- 1It is listedPlaced on a third-party e-commerce marketplace, Amazon.com
- 2It reaches the whole countryNot bound to the catchment of a physical store, it is bought across state lines
- 3Purchasers are hard to identifyWho bought how much depends on the marketplace's own records
- 4Notice is hard to deliverRemoving it from a shelf does not complete the recall
That distribution is recorded as nationwide through an online marketplace bears directly on how a recall is delivered. In a store, pulling it from the shelf stops it; retrieving what has already reached households depends on whether notice reaches the purchaser.
3One record in 1,408
There are 105 recalls citing an undeclared ingredient, and most of them concern food allergens. This is the only one citing an undeclared drug ingredient - the same word "undeclared" carrying quite different meaning.
Why it matters
Recalling a product sold through an online marketplace does not end at pulling it from a shelf: reaching purchasers depends on the marketplace's own records. Products in the supplement category found to contain drug ingredients raise questions about sourcing and analytical testing, and both the seller and the marketplace need a means of getting recall notice to the people who bought it.
FAQ
What is tadalafil?
Why is it a problem inside a dietary supplement?
Where was it sold?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: H-1196-2026