Zydus Pharmaceuticals recalls estradiol transdermal patches (0.0375mg/day) due to failed impurities. Affected lots from India manufacturer Cadila Healthcare. Stop using if you have these specific lot numbers.
Failed Impurities/Degradation Specifications.
Zydus Pharmaceuticals is recalling estradiol transdermal patches (0.0375mg/day) because they may contain impurities that could be harmful. This is a prescription-only product that was manufactured in India and distributed in the U.S. The recall affects specific batch numbers with expiration dates from October 2024 to June 2025.
The patches may contain impurities that could be harmful when used as directed. This failure in quality control could lead to adverse effects, though the exact risk is not specified in the recall notice.
Prescription patients using estradiol transdermal patches (0.0375mg/day) for hormone replacement therapy. Those with specific batch numbers from Cadila Healthcare in India are most at risk.
Check your patch label for the lot number (M310493, M308397, M305337, M400155, or M314660) and expiration date (between October 2024 and June 2025). This product is only available by prescription.
Look for the lot number (M310493, M308397, M305337, M400155, or M314660) and expiration date on the product label.
The recall is due to failed impurities and degradation specifications in the product, which could be harmful when used as directed.
The recall notice does not specify a stop-use instruction, so you should check your patch label for the lot number and expiration date to determine if it is affected.
The recall notice does not provide a remedy for affected products, so you should contact your healthcare provider for guidance.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0542-2024 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0542-2024 from Zydus Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
