Key Takeaway

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 by www.blankterrmall.com was recalled on November 19, 2017. The hazard: Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.

FDA Drug Class I Terminated

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

Recalled: November 19, 2017 ~10 boxes units affected D-0470-2018

Description

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

Hazard / Reason

Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.

Class I: Dangerous or defective product that could cause serious health problems or death.

Class I is the most serious recall classification used by the FDA, indicating a reasonable probability of serious health consequences or death.

Products Affected

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

Drugs

Company Information

www.blankterrmall.com

Olean, NY, United States

View all 1 recalls by www.blankterrmall.com →

Distribution

Product was distributed in the United States.

Related Recalls

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.