FDA Recall D-0543-2024
Zydus Pharmaceuticals (USA) Inc · Pennington, NJ
Class III Ongoing 728 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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 for recall
Failed Impurities/Degradation Specifications.
Recall record
- Recall number
D-0543-2024- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2024-05-16
- Classified by FDA Center
- 2024-06-06
- FDA published
- 2024-06-12
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Firm location
- Pennington, NJ
Drug identification
- Brand name(s)
- ESTRADIOL
- Generic name(s)
- ESTRADIOL
- Manufacturer(s)
- Zydus Pharmaceuticals USA Inc.
- NDC(s)
70710-1191, 70710-1192, 70710-1193, 70710-1194, 70710-1195- Route(s)
- TRANSDERMAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.