Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

© 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Syntho Pharmaceuticals, Inc.: EEMT and EEMT HS Hormonal Tablets Recalled for Sub-Potency and CGMP Violations

Agency Publication Date: January 16, 2019
Share:
Sign in to monitor this recall

Summary

Syntho Pharmaceuticals, Inc. is recalling approximately 10,000 bottles of EEMT and EEMT HS (esterified estrogens and methyltestosterone) tablets. These prescription hormone replacement medications were found to be sub-potent, meaning they contain less of the active ingredient than required, and were manufactured under conditions that violated current Good Manufacturing Practice (cGMP) standards. Consumers who use these medications may not receive the intended therapeutic benefit, which could lead to a recurrence of symptoms. You should consult with your healthcare provider or pharmacist regarding the continued use of this product and to arrange for a suitable replacement.

Risk

The sub-potency of these hormone tablets means patients may receive an inadequate dose of medication, potentially leading to the return of symptoms or ineffective treatment of the underlying condition. Manufacturing violations further compromise the quality and reliability of the drug product.

What You Should Do

  1. Check your medication bottles for EEMT HS (0.625 mg/1.25 mg) with NDC 15310-020-01 and Lot #: S16E01 (Exp 05/18).
  2. Check your medication bottles for EEMT (1.25 mg/2.5 mg) with NDC 15310-010-01 and Lot #: S16E02 (Exp 05/18).
  3. Contact your healthcare provider or pharmacist immediately for guidance if you are currently taking these recalled medications.
  4. Return any unused product to your pharmacy for a refund and to discuss an alternative prescription.
  5. Contact the manufacturer, Syntho Pharmaceuticals, Inc., for further instructions regarding this recall.
  6. For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Drug recall baseline remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, 100-count bottle
Model:
NDC 15310-020-01
Recall #: D-0377-2019
Lot Numbers:
S16E01 (Exp 05/18)
Date Ranges: Expiration 05/18
Product: EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, 100-count bottle
Model:
NDC 15310-010-01
Recall #: D-0378-2019
Lot Numbers:
S16E02 (Exp 05/18)
Date Ranges: Expiration 05/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81867
Status: Resolved
Manufacturer: Syntho Pharmaceuticals, Inc.
Sold By: Creekwood Pharmaceutical, Inc.
Manufactured In: United States
Units Affected: 2 products (5,000 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.