X10 and biQ-FEL supplements are recalled in a Class I action for hidden sildenafil and tadalafil

Two nationally distributed products from A&P Creations of Clermont, Florida, X10 Natural Enhancement Supplement and biQ-FEL, are the subject of a Class 1 recall because they contain undeclared sildenafil and tadalafil. The Food and Drug Administration’s enforcement database lists 1,283 retail units of X10 and 3,116 bottles of biQ-FEL, and both entries are marked as ongoing.

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Sildenafil and tadalafil are the active ingredients in prescription erectile dysfunction drugs, and neither appears on the label of either product. The recalls were initiated on Sept. 14, 2026, classified on Oct. 7 and reported in the enforcement report dated Oct. 14. The records say both products were distributed nationwide across the United States, so the products could be in homes far from Florida. The records give no list of retailers, so the data does not say where the units were sold.

The X10 and biQ-FEL recall records

The openFDA food enforcement data describes X10 as a 0.5 fluid ounce (15 mL) sachet sold seven to a box under UPC 7708075247094, manufactured by FutuPro S.A.S. in Colombia and distributed by Natur Fuel at the Clermont address. Its recall number is H-0016-2027. The affected lots are F090824LN16, which expires in August 2026, F170325LN19, which expires in March 2027, and 300326LN28, which expires in March 2028.

The companion record, H-0017-2027, covers biQ-FEL in a 16.9 fluid ounce (500 mL) bottle with 17 servings, manufactured by ALMENAT SAS in Cali, Colombia and distributed by Biofel. The listed lots are biQ-f001-06-25, with an expiry of May 6, 2027, and biQ-003-01-26, with an expiry of Jan. 1, 2028. Both records give the same reason in the same words: “Product contains undeclared Sildenafil and Tadalafil.” Both name the initial firm notification as a press release, and both share event number 99872. The firm’s initial notification was a press release, so buyers who do not see that announcement may learn of the recall only by checking the lot codes on a package they already own.

What Class 1 means for buyers

The agency’s own recall definitions describe a Class 1 recall as a situation in which there is a reasonable probability that use of or exposure to a violative product will cause serious adverse health consequences or death. Both products carry that classification in the enforcement database, and the classification date of Oct. 7 fell about three weeks after the firm began the recall on Sept. 14. Class 1 is the label reserved for situations where the agency sees a reasonable probability of serious harm, so buyers should read it as a warning to act promptly, not as a routine notice.

The enforcement data carries its own caution. It is unvalidated, and the database says it should not be used to make medical decisions, so anyone holding one of these products should treat the printed lot numbers and the company’s notice as the starting point and ask a pharmacist or physician about any health question. Shoppers who bought either product online or at a local store may not realize that a supplement sold as a natural enhancer can contain the same compounds as a prescription drug, and the labels on these two products did not say so. The records show that the recall status is ongoing, which means the count of units may be revised as the firm and the agency complete their work.

Why hidden sildenafil and tadalafil worry regulators

The danger from this kind of tampering lies partly in the drugs and partly in the fact that the buyer does not know they are there. In a public notice about another sexual enhancement product, SexRx, dated Jan. 28, 2014, the FDA said hidden sildenafil and tadalafil may interact with nitrates found in some prescription drugs, such as nitroglycerin, and could lower blood pressure to dangerous levels. The notice said men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates and face the greatest concern.

That 2014 notice concerned a different product, and it should not be read as a finding about X10 or biQ-FEL. It does show how the agency has described the risk when a “natural” supplement turns out to hold the same active ingredients as Viagra and Cialis. Its advice at the time was blunt: “Consumers should stop using this product immediately and throw it away.” Anyone who has side effects should contact a health care professional as soon as possible. A separate FDA notice on Wild Sexx Capsules describes the same hidden pair of ingredients and the same warning about nitrate medicines such as nitroglycerin. For the two recalled products, the practical step is the same: compare the lot number on the package with the lists above, and do not keep using a supplement whose label hides prescription-strength ingredients.

Adverse events can be reported to the agency through its MedWatch program. The enforcement entries do not list illnesses tied to the two products, and nothing in the data reviewed describes injuries. The recall numbers, H-0016-2027 for X10 and H-0017-2027 for biQ-FEL, are the identifiers to use if a buyer or pharmacist wants to look the entries up again, since the firm and quantity can be confirmed against them.

This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.

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