The Recall Desk
CriticalFDA (Drugs)·D-0470-2018·Announced 2018-01-31

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
Hazard
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.

Related recalls

Same hazard · undeclared ingredient

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