FDA Recalls Hard Ten Days Capsules for Unapproved Sildenafil
The FDA is recalling Hard Ten Days Capsules because they contain sildenafil, an unapproved active ingredient. Consumers should stop using the product.
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 per the rubric mandates a severity score of 5 (Critical) regardless of other factors.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Hard Ten Days Capsules, 4500 mg, boxes of 6 packets. The product is marketed as an over-the-counter (OTC) item developed by American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company. The recall is being conducted by www.vitaminbestbuy.com.
The recall is issued because the product contains sildenafil, a prescription medication, without an approved Abbreviated New Drug Application (ANDA) or New Drug Application (NDA). The source text does not specify the number of affected units, specific lot numbers, or the geographic distribution of the product.
Consumers who have purchased Hard Ten Days Capsules should stop using the product immediately. The source text does not provide specific instructions for returning the product or seeking a refund.
The recalled product
- Product
- Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet
- Manufacturer
- www.vitaminbestbuy.com
- Affected units
- 550
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 3 recalled by www.vitaminbestbuy.com 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 3 products in this recall →Related recalls
Same manufacturer · www.vitaminbestbuy.com
See all →- CriticalJapan Weight Loss Blue Capsules Recalled for Unapproved Sibutramine
FDA (Drugs) · 2012-10-03
- SevereMan King Capsules Recalled for Unapproved Sildenafil Presence
FDA (Drugs) · 2012-10-03
Same hazard · unapproved ingredient
See all →- Severe
- HighAlpha Test supplement capsules recalled for unapproved cathine ingredient
FDA (Food) · 2025-02-05
- HighTruvy Boost Dietary Supplement Kit Recalled for Unapproved Ingredients
FDA (Food) · 2023-05-31
- ModerateDietary supplement Tight! Xtreme Reloaded recalled for unapproved ingredient
FDA (Food) · 2021-06-30
- SevereFDA Recalls PremierZen Black 5000 for Unapproved Tadalafil
FDA (Drugs) · 2021-05-26
Similar recalls
- SevereFDA Recalls Unapproved Hard Ten Days Capsules Containing Sildenafil
FDA (Drugs) · 2018-02-07
- SevereHard Steel Capsules Recalled for Undeclared Acetaminophen and Sildenafil
FDA (Drugs) · 2024-10-09
- CriticalFDA Recalls Silver Bullet Male Enhancement Capsules for Undeclared Active Ingredient
FDA (Drugs) · 2020-01-08
- CriticalHard Ten Days capsules recalled for lack of FDA approval
FDA (Drugs) · 2016-06-01
- CriticalHard Times For Men capsules recalled for undeclared sildenafil
FDA (Drugs) · 2018-01-31
- SevereFDA Recalls Unapproved Libigrow XXXTREME Capsules Containing Undeclared Ingredients
FDA (Drugs) · 2013-05-22