Hard Times For Men capsules recalled for undeclared sildenafil
The FDA is recalling Hard Times For Men capsules because they contain undeclared sildenafil and were marketed without an approved NDA or ANDA.
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 Critical severity score of 5 according to the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Hard Times For Men capsules. The product is packaged in a 23-count box of blister packs containing one capsule per pack and is distributed by Natural Works LLC in the United States.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product contains an undeclared active pharmaceutical ingredient (API), specifically sildenafil.
Consumers who have purchased this product should stop using it and contact the recalling firm, www.blankterrmall.com, for further instructions. The recall covers 10 boxes of the product, with all lots within expiry.
The recalled product
- Product
- Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA
- Manufacturer
- www.blankterrmall.com
- Category
- Drug — Prescription Drug
- Affected units
- 10
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 within expiry.
Distribution
Distribution scope not specified by the agency.
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