Clalis capsules recalled for undeclared sildenafil ingredient
Fabscout Entertainment, Inc. is recalling Clalis capsules because FDA analysis found they contain sildenafil, an undeclared active pharmaceutical ingredient.
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 mandates a severity score of 5 according to the rubric.
Plain-English summary
Fabscout Entertainment, Inc. is recalling Clalis capsules, 50 mg, 6-count bottles. The product labeling is in a foreign language. The recall covers all lots of the product.
The recall is being conducted because the products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Laboratory analysis by the FDA determined that the capsules contain sildenafil, which is an undeclared active pharmaceutical ingredient.
The product was distributed nationwide and in France. Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
- Manufacturer
- Fabscout Entertainment, Inc
- Category
- Drug — Prescription 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.
Part of a larger recall action
This product is one of 2 recalled by Fabscout Entertainment, 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
Same manufacturer · Fabscout Entertainment, Inc
See all →- CriticalSilver Sword capsules recalled for undeclared sildenafil ingredient
FDA (Drugs) · 2014-03-26
- CriticalEvil Root 1200 mg Recalled for Undeclared Sildenafil
FDA (Drugs) · 2013-12-25
- CriticalDietary Supplement Recalled for Undeclared Sildenafil and Lack of FDA Approval
FDA (Drugs) · 2013-12-25
- CriticalPRO POWER MAX Energy Capsules Recalled for Undeclared Sildenafil and Tadalafil
FDA (Drugs) · 2013-12-25
Same hazard · undeclared ingredient
See all →- ModerateWise Onion Rings recalled for undeclared food color additives
FDA (Food) · 2026-07-15
- ModerateDietary supplement Ocular Plus recalled for undeclared Yellow #5
FDA (Food) · 2026-07-08
- ModerateDietary Supplement Vista MAX Recalled for Undeclared Yellow #5 Allergen
FDA (Food) · 2026-07-08
- ModerateEl David Gelee Bonbons Recalled for Undeclared Color Additives
FDA (Food) · 2026-07-01
- HighAdndale magnesium glycinate gummies contain undeclared melatonin in three lots
FDA (Food) · 2026-06-24
Similar recalls
- SevereFDA Recalls Unapproved Clalis Capsules Containing Sildenafil
FDA (Drugs) · 2018-02-07
- CriticalFDA Recalls Black Label X Capsules for Undeclared Sildenafil
FDA (Drugs) · 2016-12-28
- SevereDietary supplement found to contain undeclared pharmaceutical drug tadalafil
FDA (Drugs) · 2022-07-27
- SevereFDA Recalls Unapproved Black Ant Capsules Containing Sildenafil
FDA (Drugs) · 2018-02-07
- CriticalMagic Slim capsules recalled for undeclared pharmaceutical ingredients
FDA (Drugs) · 2014-06-18
- SevereUnapproved Yanshijiaonang Capsules Containing Sildenafil Recalled by FDA
FDA (Drugs) · 2018-02-07