CLASS III Drug recall · Reported 10 Jul 2019 · FDA Enforcement Report

Esterified Estrogens & Methyltestosterone Tablets recalled

Amneal Pharmaceuticals is recalling Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, distributed nationwide in the US. The recall was initiated on 25 Sep 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: HL05715, HL05815, Exp. 11/2017

Quantity recalled19104 units

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1438-2019
FDA event ID: 83137
Recalling firm: Amneal Pharmaceuticals, Brookhaven, NY
Classification: Class III
Status: Terminated
Recall initiated: 25 Sep 2017
FDA classified: 1 Jul 2019
Reported: 10 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Hormones & Birth Control

Timeline

25 Sep 2017	Recall initiated by company
1 Jul 2019	Classified by FDA	+644 days
10 Jul 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot #: HL05715, HL05815, Exp. 11/2017

Where was it sold?

Nationwide within the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 83137

This product is part of a recall event; the main page for the event is Esterified Estrogens & Methyltestosterone Tablets recalled.

Reported	Class	Recall	Company	Reason	Where
10 Jul 2019	CLASS III	Esterified Estrogens & Methyltestosterone Tablets recalled	Amneal Pharmaceuticals	Potency & Assay	Nationwide

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Other Esterified Estrogens & Methyltestosterone recalls

All 2

Reported	Class	Recall	Company	Reason	Where
10 Jul 2019Drug	CLASS III	Esterified Estrogens & Methyltestosterone Tablets recalled	Amneal Pharmaceuticals	Potency & Assay	Nationwide