Class III · Lower riskActive recall
Estradiol
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: M310493, Exp. Date 01/2025; M308397, Exp. Date 11/2024; M305337, Exp. Date 10/2024; M400155, Exp. Date 06/2025; M314660, Exp. Date 05/2025
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
Failed Impurities/Degradation Specifications.
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 byCadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 foreign manufacturer
| Brand name | ESTRADIOL |
| Generic name | ESTRADIOL |
| Active ingredient(s) | ESTRADIOL |
| Distributed by / for | Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 |
| NDC | 70710-1192-8 |
Show the full FDA record
| Full product label | Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8 |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc |
| Distribution | Nationwide within the United States |
| Quantity | 21,360 units |
| Recall initiated | 2024-05-16 |
| Report date | 2024-06-12 |
| Recall completed | — |
| Recall number | D-0542-2024 |
| Classification | Class III |
| FDA status | Ongoing |
| Origin on file | Pennington NJ 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.