Estradiol transdermal patches recalled for failed quality specifications
Zydus Pharmaceuticals is recalling 13,440 units of Estradiol transdermal patches distributed nationwide due to failed impurities and degradation specifications. No illnesses or injuries have been reported.
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 recall with no reported illnesses or injuries and a theoretical hazard. Per the rubric, Class III recalls without reported harm score 1–2, fitting the 'voluntary precautionary recall' criterion for Moderate severity.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc is recalling Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day patches. The affected product consists of 13,440 units distributed nationwide within the United States. The recalled lots are #M311202 (expiring February 2025) and #M311201 (expiring January 2025), manufactured by Cadila Healthcare Limited in Ahmedabad, India.
The recall was initiated because certain batches failed to meet FDA specifications for impurities and degradation. The company identified these specification failures during quality control testing.
This is a prescription medication. Patients taking Estradiol patches should check with their healthcare provider or pharmacist if their medication is from the affected lots, using the lot numbers and expiration dates provided. This is an FDA Class III recall.
The recalled product
- Product
- ESTRADIOL (ESTRADIOL)
- Brand
- ESTRADIOL
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug
- Hazard
- Affected units
- 13,440
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 (4)
- Lot #: M311202
- Exp. Date 2/25
- M311201
- Exp. Date 1/25
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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