Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Apr 17, 2017 (9 years ago)

EEMT HS (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.

Cause type: Wrong potency / content

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 HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01

Affected NDC 15310-0020-01

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

Drug: Testosterone

Recalling firm
Syntho Pharmaceuticals, Inc.
NDC code
15310-020-01
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0377-2019 · 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.

Other Testosterone recalls

See all
Class II · Moderate risk

Testosterone 200mg

Presence of Foreign substance - potential presence of metal particulate matter

Ongoing Particulate / foreign matter F.H. INVESTMENTS, Inc. (dba Asteria Health) D-0329-2026
Class II · Moderate risk

Testosterone 100mg

Presence of Foreign substance - potential presence of metal particulate matter

Ongoing Particulate / foreign matter F.H. INVESTMENTS, Inc. (dba Asteria Health) D-0328-2026
Class II · Moderate risk

Testosterone 75mg

Presence of Foreign substance - potential presence of metal particulate matter

Ongoing Particulate / foreign matter F.H. INVESTMENTS, Inc. (dba Asteria Health) D-0327-2026

Other recalls by Syntho Pharmaceuticals, Inc.

All 2017 recalls