CLASS I ONGOING Drug recall · Reported 18 Nov 2015 · FDA Enforcement Report
Miracle Rock recalled by The One Minute Miracle
The One Minute Miracle is recalling Miracle Rock, distributed nationwide in the US. The recall was initiated on 27 Aug 2015 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0229-2016
- FDA event ID
- 72058
- Recalling firm
- The One Minute Miracle, North Miami Beach, FL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 27 Aug 2015
- FDA classified
- 12 Nov 2015
- Reported
- 18 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
Timeline
| 27 Aug 2015 | Recall initiated by company | |
| 12 Nov 2015 | Classified by FDA | +77 days |
| 18 Nov 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Is Miracle Rock recalled?
Yes. The One Minute Miracle recalled Miracle Rock on 27 Aug 2015. The recall is Class I and its status is Ongoing. Recall number D-0229-2016.
Why was it 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 lots are affected?
All lots through Expiration Date 06/01/2018
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from The One Minute Miracle
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Miracle Diet, Manufactured Exclusively recalled | The One Minute Miracle | Labeling Errors | Nationwide |