EEMT (esterified estrogens and methyltestosterone)

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.

What was recalled

EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-010-01

Affected NDC 15310-0010-01

Compare with the code on your package — it is the most precise check available.

Drug: Testosterone

Recalling firm: Syntho Pharmaceuticals, Inc.
NDC code: 15310-010-01
Origin: NY, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0378-2019 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.