Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Estriol Recalled by Asclemed USA Inc. dba Enovachem Pharmaceuticals Due to Failed Impurities/Degradation Specifications: Additional testing found Out of...

Date: December 9, 2019
Company: Asclemed USA Inc. dba Enovachem Pharmaceuticals
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Asclemed USA Inc. dba Enovachem Pharmaceuticals directly.

Affected Products

Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38

Quantity: 56.4 gm

Why Was This Recalled?

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

Where Was This Sold?

Product was distributed to 6 physician's offices within the state of California.

About Asclemed USA Inc. dba Enovachem Pharmaceuticals

Asclemed USA Inc. dba Enovachem Pharmaceuticals has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report