Syntho Pharmaceuticals Recalls EEMT HS Tablets Due to Sub-Potency and CGMP Violations
Syntho Pharmaceuticals recalls 100-count EEMT HS tablets (0.625 mg/1.25 mg) manufactured with CGMP deviations. Sub-potency and quality issues may affect medication effectiveness.
Lower-risk recall
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Contact the company
What happened, in plain English
Syntho Pharmaceuticals is recalling 100-count EEMT HS tablets (0.625 mg/1.25 mg) due to sub-potency and CGMP violations. This means the medication may not work as intended, potentially affecting treatment outcomes. Read more at govinfonow.com/recall/41752-syntho-pharmaceuticals-recalls-eemt-hs-tablets-due-to-sub-potency.
Source Summary by GovInfoNow · govinfonow.com/recall/41752-syntho-pharmaceuticals-recalls-eemt-hs-tablets-due-to-sub-potency · Updated October 8, 2026 · FDA enforcement record: FDA #D-0377-2019
Cite this page
“Syntho Pharmaceuticals Recalls EEMT HS Tablets Due to Sub-Potency and CGMP Violations.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41752-syntho-pharmaceuticals-recalls-eemt-hs-tablets-due-to-sub-potency. Based on FDA recall #D-0377-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0377-2019%22&limit=1).
Why it’s dangerous
The tablets were manufactured with CGMP deviations, leading to sub-potency. This means the medication may not contain the intended active ingredients in sufficient amounts, reducing effectiveness. However, the recall does not indicate immediate safety risks like injury or death.
Who’s affected
Prescription patients using the recalled EEMT HS tablets for hormone therapy. Those with specific medical conditions requiring precise hormone levels are at higher risk.
How to tell if you have this one
Check for the 100-count bottle labeled EEMT HS (0.625 mg/1.25 mg) with NDC 15310-020-01. The lot number S16E01 was manufactured in Farmingdale, NY and expires May 2018.
- Brand
Syntho Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Product was sold to the firm's sole distributor who further distributed the product throughout the United States.
| Recall number | Product, codes & lots |
|---|---|
| D-0377-2019 | 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; Lot #: S16E01, Exp 05/18 |
| D-0378-2019 | 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; Lot #: S16E02, Exp 05/18 |
What to do — step by step
Check Medication Details
Verify the product label for the 100-count EEMT HS tablets with NDC 15310-020-01 and lot number S16E01.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was sold to the firm's sole distributor who further distributed the product throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0377-2019 (April 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0377-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.