Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
52 recalls
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Class I Ongoing
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.
Lots, distribution and details
- Lots / codes
- All lots through Expiration Date 06/01/2018
- Distribution
- Nationwide
- Quantity
- 688 cartons
- Recall started
- August 27, 2015 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0229-2016
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Class I Ongoing
Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS
Reason: Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug
Lots, distribution and details
- Lots / codes
- None
- Distribution
- Utah
- Quantity
- 50,000 capsules
- Recall started
- March 10, 2012 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-266-2013
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.