FDA Drug recall D-0229-2016
MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Mirac…
- FDA Drug
- Class I
- ongoing
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class I recall of MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Mirac… by The One Minute Miracle, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0229-2016 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2015-08-27 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | The One Minute Miracle |
| Distribution | US |
Product
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
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.
Identifiers
| upc | 0911312397354 |
|---|---|
| code_info | All lots through Expiration Date 06/01/2018 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0229-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.