Hard Steel Capsules packaged in blister packs in boxes of 10 recalled over undeclared acetaminophen

Recall date

July 12, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Supercore Products Group Inc. recalls Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.

Recall number

D-0003-2025

FDA classification

Class I

Brand / firm

Supercore Products Group Inc.

Sold / distributed

Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)

Why it was recalled

Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.