Class III · Lower riskRecall completed
Esterified Estrogens & Methyltestosterone Tablets
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: HL06015, HL06115, Exp. 10/2017
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAmmeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736
| Distributed by / for | Seton Pharmaceuticals Manasquan, NJ 08736 |
| NDC | 13925-172-01 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Amneal Pharmaceuticals, Inc. |
| Distribution | Nationwide within the United States |
| Quantity | 19176 units |
| Recall initiated | 2017-09-25 |
| Report date | 2019-07-10 |
| Recall completed | 2019-08-08 |
| Recall number | D-1439-2019 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Brookhaven NY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.