VitalityXtra Capsules Recalled for Undeclared Sildenafil and Diclofenac
VitalityXtra Capsules containing undeclared sildenafil and diclofenac are being recalled nationwide. The product was marketed without required FDA approval and poses health risks from undeclared 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: FDA Class I classification requires a minimum severity score of 4 per the recall rubric. This classification reflects the serious risks associated with undeclared pharmaceutical ingredients, including potential adverse reactions and harmful drug interactions.
Plain-English summary
VitalityXtra Capsules, 500 mg, distributed by VitalityXtra (San Francisco, CA) are being recalled. The product is packaged in 10 count blisters in cartons with Lot #230811 (expiration 08/11/2025), manufactured by Boulla LLC.
This is a Class I recall because the product contains undeclared sildenafil and diclofenac and was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The recalled product was distributed nationwide within the United States. Consumers who have purchased this product should stop using it and consult with a healthcare provider, particularly if they take other medications.
The recalled product
- Product
- VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
- Manufacturer
- Boulla LLC
- Category
- Drug — Dietary Supplement
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 (2)
- Lot #: 230811
- Exp: 08/11/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Boulla LLC 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.
See all 4 products in this recall →Related recalls
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