MIRACLE ROCK 48 capsules — Class I drug recall D-0229-2016
Ongoing recall by The One Minute Miracle Inc, reported 2015-11-18, distributed nationwide. Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an anal
| Recall number | D-0229-2016 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | The One Minute Miracle Inc, North Miami Beach, FL, United States |
| Recall initiated | 2015-08-27 |
| Classified | 2015-11-12 |
| Reported by FDA | 2015-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 688 cartons |
| Reason classes | undeclared allergen, unapproved product |
| UPC / GTIN / UDI-DI | 00911312397354 |
| Expiration dates | 2018-06-01 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0229-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.