Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling 34,800 units of Estradiol Transdermal System, USP (Twice-Weekly) in 0.0375mg/day and 0.025mg/day strengths. This recall was initiated because the products failed to meet specifications for impurities and degradation. Consumers using this prescription medication for hormone replacement therapy should contact their healthcare provider to discuss alternative treatments.
The affected patches may contain chemical impurities or degradation products that exceed the approved safety limits. While the risk of serious adverse health consequences is considered low, using medication that does not meet established quality standards can lead to unpredictable safety profiles or reduced efficacy.
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Manufactured by Cadila Healthcare Limited, Ahmedabad, India
Manufactured by Cadila Healthcare Limited, Ahmedabad, India
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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