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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83137

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 25, 2017
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Amneal Pharmaceuticals, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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

D-1438-2019
Recall number
D-1438-2019
Initiated
September 25, 2017
Classification
Class III
Status
Terminated
Quantity
19104 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Nationwide within the United States

drug · product 2 of 2

Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01

D-1439-2019
Recall number
D-1439-2019
Initiated
September 25, 2017
Classification
Class III
Status
Terminated
Quantity
19176 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: HL06015, HL06115, Exp. 10/2017

Distribution pattern

Nationwide within the United States