FDA Recalls 7K Capsules Containing Undeclared Sildenafil and Tadalafil
The FDA is recalling 7K capsules distributed by SX Power Co. because they contain undeclared sildenafil and tadalafil, making them unapproved drugs with unestablished safety and efficacy.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which corresponds to a reasonable probability of serious adverse health consequences or death, meeting the criteria for a Critical severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 7K capsules packaged in single packs sold in 24-count boxes. The product is distributed by SX Power Co. in San Diego, California, and manufactured by Shoreside Enterprises Inc. The specific lot number is RO, with an expiration date of 12/31/2021. The product was distributed nationwide.
The recall was initiated because FDA analysis found that the products contain undeclared sildenafil and tadalafil. The presence of these active pharmaceutical ingredients makes the products unapproved drugs for which safety and efficacy have not been established. Consequently, the products are subject to recall under FDA regulations.
Consumers who have purchased these 7K capsules should stop using them immediately. The source text does not specify a particular consumer action such as returning the product to a retailer or contacting a specific phone number, but standard FDA guidance for unapproved drugs containing undeclared ingredients is to discontinue use.
The recalled product
- Product
- 7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
- Manufacturer
- Shoreside Enterprises Inc.
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 #: RO
- Exp. 12/31/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Shoreside Enterprises 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.
See all 2 products in this recall →Related recalls
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