Spanish Fly 22K Capsules Recalled for Undeclared Prescription Drug Ingredients
Spanish Fly 22K capsules contain undeclared sildenafil and/or tadalafil and were marketed without FDA approval. The product poses serious health risks from these unapproved pharmaceutical ingredients.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this as a Class I recall, the most serious category, indicating a serious hazard where use of the unapproved product containing undeclared prescription drug ingredients poses a risk of serious adverse health consequences. No deaths or illnesses have been reported in the source.
Plain-English summary
Spanish Fly 22K capsules, marketed in 2-count boxes, are being recalled because they contain undeclared sildenafil and/or tadalafil—active pharmaceutical ingredients found in prescription medications. The product was marketed and sold without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), meaning it was not reviewed or approved by the FDA.
Undeclared prescription drug ingredients pose serious health risks. Consumers may unknowingly take these pharmaceutical ingredients, which could cause serious adverse effects, particularly if they take other medications or have certain medical conditions that interact with these substances. The FDA has classified this recall as Class I, the most serious classification.
The recall affects 45 boxes of the product distributed nationwide. Consumers who have purchased Spanish Fly 22K capsules should stop using the product immediately and contact a healthcare provider if they have consumed it. The product should not be used or distributed further.
The recalled product
- Product
- Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
- Manufacturer
- Pyramids Wholesale Inc.
- Category
- Drug — Unapproved Drug
- Affected units
- 45
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Pyramids Wholesale Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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