FDA Drug recall D-1438-2019
Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceutical…
- FDA Drug
- Class III
- terminated
- Published 2019-07-10
On 2019-07-10 the FDA classified a Class III recall of Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceutical… by Amneal Pharmaceuticals, citing subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1438-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-09-25 |
| Published | 2019-07-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | US |
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
Reason
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Identifiers
| code_info | Lot #: HL05715, HL05815, Exp. 11/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1438-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.