Esterified Estrogens & Methyltestosterone Tablets — Class III drug recall D-1439-2019
Terminated recall by Amneal Pharmaceuticals, Inc., reported 2019-07-10, distributed nationwide. Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
| Recall number | D-1439-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals, Inc., Brookhaven, NY, United States |
| Recall initiated | 2017-09-25 |
| Classified | 2019-07-01 |
| Reported by FDA | 2019-07-10 |
| Terminated | 2019-08-08 |
| Distributed | Nationwide (US) |
| Quantity | 19,176 units |
| Reason classes | potency, specification failure |
| NDC | 13925-0172-01 |
| Lot numbers | HL06015, HL06115 |
| Expiration dates | 2017-10 |
Product
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
Reason for recall
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1439-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.