Drug FDA Class III Ongoing Failed specifications
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
Zydus Pharmaceuticals (USA) Inc Published Jun 12, 2024
Risk level
Class IIIUnlikely to cause harm, but violates labeling or manufacturing rules.
Severity score 40/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Zydus Pharmaceuticals (USA) Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Failed Impurities/Degradation Specifications.
Hazards
Failed Impurities/Degradation Specifications · primary
Affected products (1)
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
ESTRADIOL · 13,440 units
NDC: 70710-1191, 70710-1192, 70710-1193, 70710-1194, 70710-1195, 70710-1191-1, 70710-1191-8, 70710-1192-1, 70710-1192-8, 70710-1193-1, 70710-1193-8, 70710-1194-1, 70710-1194-8, 70710-1195-1, 70710-1195-8
Code info: Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25
Affected areas
Nationwide
Timeline
- InitiatedMay 16, 2024
- PublishedJun 12, 2024
- Recall number
- D-0543-2024
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.