Estradiol Transdermal System recall
FDA recall D-0542-2024 · initiated May 16, 2024
Zydus Pharmaceuticals (USA) Inc recalled Estradiol Transdermal System in May 2024 — an FDA Class III recall (D-0542-2024) because Failed Impurities/Degradation Specifications.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 21,360 units
Details
- 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
- Recalling company
- Zydus Pharms
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- May 16, 2024
- FDA report date
- Jun 12, 2024
Frequently asked
- Was Estradiol Transdermal System recalled?
- Zydus Pharmaceuticals (USA) Inc recalled Estradiol Transdermal System in May 2024 — an FDA Class III recall (D-0542-2024) because Failed Impurities/Degradation Specifications. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Estradiol Transdermal System recalled?
- Per the FDA enforcement record, the reason for recall D-0542-2024 was: Failed Impurities/Degradation Specifications.
- Is a recalled Estradiol Transdermal System dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Estradiol Transdermal System are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — 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. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0542-2024.