Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class I drug recalls - the high-risk category

Class I is the FDA's most serious recall category: a reasonable probability that using the product will cause serious health consequences or death. It is a small share of all recalls, but the one to check first if a medication you take appears here.

1,750 recalls, newest first.

Class I · High risk

Americaine

Chemical Contamination: presence of benzene

Completed Chemical / undeclared Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company NDC 63736-378-02 D-0236-2024
Class I · High risk

Magnum XXL 9800

Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.

Ongoing Chemical / undeclared Meta Herbal D-0206-2024
Class I · High risk

SANDIMMUNE Oral Solution

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals

Ongoing Failed specification Novartis Pharmaceuticals Corporation NDC 0078-0110-22 D-0144-2024

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