Vitility Recalls MAN OF STEEL Capsules Containing Undeclared Sildenafil
Vitility is recalling MAN OF STEEL capsules because FDA analysis found they contain undeclared sildenafil, an unapproved drug 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 mandates a severity score of 5 according to the rubric.
Plain-English summary
Vitility is recalling MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, packaged for One Drop Solutions, LLC. The product is distributed nationwide in the USA. The recall involves 75 packets labeled with an expiration date of 10-17-2018 and no lot number.
The U.S. Food and Drug Administration (FDA) initiated this recall because FDA analysis found the product contains undeclared sildenafil. Sildenafil is an FDA-approved drug for the treatment of erectile dysfunction. Because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), it is considered an unapproved drug for which safety and efficacy have not been established.
Consumers who have purchased MAN OF STEEL capsules should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; [email protected]; www.manofsteelpills.com; UPC 1 0001001378 7.
- Manufacturer
- Vitility
- Category
- Drug — Supplement
- Affected units
- 75
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)
- No Lot #: labeled Expires: 10-17-2018
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · undeclared drug
See all →- SeverebiQ-FEL Beverage Recalled for Undeclared Sildenafil and Tadalafil
FDA (Food) · 2026-10-14
- SevereFDA Recalls X10 Supplement Containing Undeclared Sildenafil and Tadalafil
FDA (Food) · 2026-10-14
- SevereSamurai-X Honey 6800 Recalled for Undeclared Drug Ingredients
FDA (Drugs) · 2024-05-01
- SevereFDA Recalls Flower Power Female Enhancement for Undeclared Sildenafil and Tadalafil
FDA (Drugs) · 2024-05-01
- SevereDietary supplement found to contain undeclared pharmaceutical drug tadalafil
FDA (Drugs) · 2022-07-27
Similar recalls
- SevereFDA Recalls Unapproved MAX MAN Capsules Containing Sildenafil
FDA (Drugs) · 2018-02-07
- SevereDietary Supplement Tainted with Undeclared Sildenafil and Tadalafil
FDA (Drugs) · 2025-03-26
- CriticalFDA Recalls Unapproved ROCK-IT MAN Male Sexual Stimulant Capsules
FDA (Drugs) · 2013-05-22
- CriticalUP2 Libido Supplement Recalled for Undeclared Sildenafil
FDA (Drugs) · 2020-03-25
- CriticalHard Times For Men capsules recalled for undeclared sildenafil
FDA (Drugs) · 2018-01-31
- SevereMan King Capsules Recalled for Unapproved Sildenafil Presence
FDA (Drugs) · 2012-10-03