Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Esterified Estrogens & Methyltestosterone Tablets Recalled by Amneal Pharmaceuticals, Inc. Due to Subpotent Drug: Out of specification assay result in...

Date: September 25, 2017
Company: Amneal Pharmaceuticals, Inc.
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 Amneal Pharmaceuticals, Inc. directly.

Affected Products

Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01

Quantity: 19104 units

Why Was This Recalled?

Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Amneal Pharmaceuticals, Inc.

Amneal Pharmaceuticals, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

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