FDA Drug recall D-0542-2024
Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distr…
- 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) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distr… by Zydus Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0542-2024 |
| 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) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8
Reason
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 #: 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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2026-08-12 · Zydus Pharmaceuticals Usa - Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed…
FDA Drug · Class II · 2026-05-27 · Zydus Pharmaceuticals Usa - Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed…
FDA Drug · Class II · 2026-05-27 · Zydus Pharmaceuticals Usa - Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt
FDA Drug · Class II · 2026-03-18 · Zydus Pharmaceuticals Usa
All Zydus Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0542-2024%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.