Class I
Drug Recall: Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Supercore Products Group Inc. · July 12, 2024
Reason for Recall
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Distribution
Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)
States Affected
NATIONWIDE
Quantity Affected
729
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0003-2025
Status: ongoing
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