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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- undeclared-sildenafil
- undeclared-tadalafil
- unapproved-drug
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.
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