One Minute Miracle Miracle Rock capsules Recall: FDA Class I

Why it was 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.

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.

Lot numbers, UPCs & expiration codes

All lots through Expiration Date 06/01/2018

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0229-2016
Classification: Class I
Status: Ongoing
Recall initiated: Aug 27, 2015
FDA report date: Nov 18, 2015
Quantity: 688 cartons
Recall type: Voluntary: Firm initiated
Recalling firm: The One Minute Miracle Inc

Original FDA data

Every field from FDA enforcement report D-0229-2016, exactly as published.

Show all FDA fields

City: North Miami Beach
State: FL
Status: Ongoing
Country: United States
Event ID: 72058
Address: 3322 NE 166th St
Code information: All lots through Expiration Date 06/01/2018
Postal code: 33160-3844
Report date: Nov 18, 2015
Product type: Drugs
Recall number: D-0229-2016
Classification: Class I
Recalling firm: The One Minute Miracle Inc
Product quantity: 688 cartons
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.
Voluntary / mandated: Voluntary: Firm initiated
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.
Distribution pattern: Nationwide
Recall initiation date: Aug 27, 2015
Initial firm notification: E-Mail
Center classification date: Nov 12, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0229-2016, published Nov 18, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

The One Minute Miracle MIRACLE ROCK 48 capsules Recall

Summary