Estradiol Transdermal Patch Recalled for Failed Chemical Specifications
Zydus Pharmaceuticals is recalling Estradiol Transdermal System patches nationwide due to failed impurities and degradation specifications. The recall affects 21,360 units distributed throughout the United States.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recalls are typically scored 1 or 2. This recall involves failed chemical specifications with no reported illnesses or injuries, making it a precautionary quality-control recall. The Class III classification and absence of patient harm support a Moderate (2) score.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day patches. The product was manufactured by Cadila Healthcare Limited in Ahmedabad, India, and distributed by Zydus Pharmaceuticals. A total of 21,360 units have been recalled nationwide.
The recall was initiated due to failed impurities and degradation specifications. The product failed to meet established standards for chemical purity and degradation limits, raising concerns about product quality and consistency.
The affected patches were distributed nationwide throughout the United States. Specific lot numbers under recall include M310493 (expiration 01/2025), M308397 (expiration 11/2024), M305337 (expiration 10/2024), M400155 (expiration 06/2025), and M314660 (expiration 05/2025).
Patients taking the recalled patches should contact their healthcare provider or pharmacist immediately. Do not stop taking medication without consulting a healthcare professional. Return recalled patches to your pharmacy or dispose of them as directed by a healthcare provider.
The recalled product
- Product
- ESTRADIOL (ESTRADIOL)
- Brand
- ESTRADIOL
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Transdermal Patch
- Hazard
- Affected units
- 21,360
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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
UPCs (3)
- 0370710119188
- 0370710119485
- 0370710119287
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Zydus Pharmaceuticals (USA) Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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