FDA Drug recall D-0543-2024
Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distri…
- FDA Drug
- Class III
- ongoing
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class III recall of Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distri… by Zydus Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0543-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-05-16 |
| Published | 2024-06-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8
Reason
Failed Impurities/Degradation Specifications.
Identifiers
| ndc | 70710-1191-1 |
|---|---|
| ndc | 70710-1191-8 |
| ndc | 70710-1192-1 |
| ndc | 70710-1192-8 |
| ndc | 70710-1193-1 |
| ndc | 70710-1193-8 |
| ndc | 70710-1194-1 |
| ndc | 70710-1194-8 |
| ndc | 70710-1195-1 |
| ndc | 70710-1195-8 |
| code_info | Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0543-2024%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.