Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported January 31, 2018
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
Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
www.blankterrmall.com recalled Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one c… - a critical-severity action.
Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one c… was recalled by www.blankterrmall.com in January 31, 2018. Reason: Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - S…. Check the official notice for the remedy. Verify recall #D-0470-2018 with the FDA Drug before acting.
The recall
www.blankterrmall.com issued this critical-severity FDA Drug recall-Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - S….
- Critical
- severity level
- Class I
- classification
- January 31, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0470-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0470-2018) was formally reported on January 31, 2018, with the manufacturer initiating the action on November 19, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. www.blankterrmall.com is listed as the recalling firm, operating out of Olean, NY. Federal records list the affected scope as 10 boxes.
The documented reason for this recall is: Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil. Distribution data in the federal record shows the product reached: Product was distributed in the United States.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,436 drugs & medications recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10 boxes
Related Recalls
6
6 from same agency
Product 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
Reason for recall
Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0470-2018 |
| Date reported | January 31, 2018 |
| Date initiated | November 19, 2017 |
| Recalling firm | www.blankterrmall.com |
| Firm location | Olean, NY |
| Affected scope | 10 boxes |
| Distribution | Product was distributed in the United States. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0470-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 by www.blankterrmall.com. Units affected: 10 boxes.
Why was this product recalled? ▼
Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 31, 2018. Severity: Critical. Recall number: D-0470-2018.
Where was the recalled product distributed? ▼
Distribution: Product was distributed in the United States..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0470-2018) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Drugs & Medications · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
Showing 5 of 14436 other recalls in this category.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported January 31, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.