FDA Recalls Bull Capsules Tainted with Sildenafil
BYL Solutions Inc. is recalling Bull Capsules marketed without an approved NDA/ANDA and found to be tainted with sildenafil.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low probability of adverse health consequences. The hazard involves an unapproved drug ingredient (sildenafil) in a supplement, which is a significant regulatory and safety issue but does not meet the criteria for higher severity scores without reported injuries or a Class I/II designation.
Plain-English summary
BYL Solutions Inc. is recalling Bull Capsules, 1800 mg/grain, 30 count per tin. The product was manufactured by Hongkong Jiuyuejiu Biology Technology CO., LTD and distributed nationwide by BYL Solutions, Inc. dba Nutra Labs, Inc., located in Palmetto, FL.
The recall was initiated because the product was marketed without an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and was found to be tainted with sildenafil. Sildenafil is an active pharmaceutical ingredient used to treat erectile dysfunction and pulmonary arterial hypertension, and its presence in unapproved dietary supplements poses a safety risk.
Consumers who have purchased Bull Capsules should stop using the product and contact BYL Solutions Inc. for further instructions. The recall covers all lots remaining within their expiry date.
The recalled product
- Product
- Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL Solutions, Inc. dba Nutra Labs, Inc., Palmetto, FL
- Manufacturer
- BYL Solutions Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 329
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 remaining within expiry.
Distribution
Distributed nationwide across the United States.
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