Severity
Critical
CriticalClass IOngoing
FDA Drug recall · Reported November 18, 2015
MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354.
Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making th…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
The One Minute Miracle Inc recalled MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, … - a critical-severity action.
MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, … was recalled by The One Minute Miracle Inc in November 18, 2015. Reason: Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an ana…. Check the official notice for the remedy. Verify recall #D-0229-2016 with the FDA Drug before acting.
The recall
The One Minute Miracle Inc issued this critical-severity FDA Drug recall-Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an ana….
- Critical
- severity level
- Class I
- classification
- November 18, 2015
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0229-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0229-2016) was formally reported on November 18, 2015, with the manufacturer initiating the action on August 27, 2015. It is classified under Critical severity (Class I), with a current status of Ongoing. The One Minute Miracle Inc is listed as the recalling firm, operating out of North Miami Beach, FL. Federal records list the affected scope as 688 cartons.
The documented reason for this recall is: Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug. Distribution data in the federal record shows the product reached: Nationwide. 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, 5 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 - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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
688 cartons
Related Recalls
6
5 from same agency
Product description
MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354.
Reason for recall
Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | D-0229-2016 |
| Date reported | November 18, 2015 |
| Date initiated | August 27, 2015 |
| Recalling firm | The One Minute Miracle Inc |
| Firm location | North Miami Beach, FL |
| Affected scope | 688 cartons |
| Distribution | Nationwide |
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-0229-2016) 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? ▼
MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354.. Recalled by The One Minute Miracle Inc. Units affected: 688 cartons.
Why was this product recalled? ▼
Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 18, 2015. Severity: Critical. Recall number: D-0229-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0229-2016) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 November 18, 2015. 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 July 2026.