Estradiol Transdermal System — Class III drug recall D-0542-2024
Ongoing recall by Zydus Pharmaceuticals (USA) Inc, reported 2024-06-12, distributed nationwide. Failed Impurities/Degradation Specifications.
| Recall number | D-0542-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2024-05-16 |
| Classified | 2024-06-06 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| Quantity | 21,360 units |
| Reason classes | specification failure |
| NDC | 70710-1191, 70710-1191-01, 70710-1191-08, 70710-1192, 70710-1192-01, 70710-1192-08, 70710-1193, 70710-1193-01, 70710-1193-08, 70710-1194, 70710-1194-01, 70710-1194-08, 70710-1195, 70710-1195-01, 70710-1195-08 |
| Lot numbers | M305337, M308397, M310493, M314660, M400155 |
| Expiration dates | 2024-10, 2024-11, 2025-01, 2025-05, 2025-06 |
Product
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
Reason for recall
Failed Impurities/Degradation Specifications.
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-0542-2024. 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.