Reported Jun 12, 2024 · Ongoing

Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited,…

Zydus Pharmaceuticals (USA) Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zydus Pharmaceuticals (USA) Inc · 73 Route 31 N · Pennington, NJ · 08534-3601

Is this the product you have?

  • Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only
  • Manufactured byCadila Healthcare Limited, Ahmedabad, India
  • Distributed byZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8
Lot codes and dates
    • Lot #: M311202
    • Exp. Date 2/25
    • M311201
    • Exp. Date 1/25
Amount recalled
13,440 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Zydus Pharmaceuticals (USA) Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 7:24 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.