The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1438-2019·Announced 2019-07-10

Amneal Recalls Subpotent Esterified Estrogens and Methyltestosterone Tablets

Amneal Pharmaceuticals is recalling specific lots of Esterified Estrogens & Methyltestosterone tablets due to out-of-specification assay results.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

Amneal Pharmaceuticals, Inc. is recalling 19,104 units of Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles. The affected product is identified by NDC 13925-171-01 and includes Lot # HL05715 and HL05815, both with an expiration date of 11/2017. The product was distributed nationwide within the United States by Seton Pharmaceuticals.

The recall was initiated because the tablets failed to meet specification for assay results, meaning the amount of active ingredients in the product was not within the required range. This is classified as a subpotent drug issue.

Consumers and healthcare providers should check their inventory for the specific lot numbers and NDC listed above. If the product is found, it should be returned to the pharmacy or distributor for disposal or credit. Patients should consult their healthcare provider for alternative treatment options if they have been using this medication.

The recalled product

Product
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
Manufacturer
Amneal Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
19,104

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Amneal Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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