Esterified Estrogens & Methyltestosterone Tablets
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Most common reason: Wrong potency / content (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Methyltestosterone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Lack of Processing Controls
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