Stop using now Drug recall · FDA · Published May 16, 2024

Zydus Estradiol Transdermal System Recall: Impurities Risk Serious Injury

Zydus Pharmaceuticals recalls estradiol transdermal system (0.025mg/day) due to failed impurities and degradation. Rx-only product with specific lot numbers and expiration dates. Stop using immediately if affected.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0543-2024Drug Zydus Pharmaceuticals ›

Stop using this now

Failed Impurities/Degradation Specifications.

Take action

Contact the company

Recalling firmZydus Pharmaceuticals (USA) Inc73 Route 31 N · Pennington, NJ 08534-3601

✎ GovInfoNow plain-language explainer

Zydus Pharmaceuticals is recalling estradiol transder: a hormone patch for women with specific lot numbers. The product may contain harmful impurities that could cause serious injury if used as directed. Read more at govinfonow.com/recall/32665-zydus-estradiol-transdermal-system-recall-impurities-risk-serious-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/32665-zydus-estradiol-transdermal-system-recall-impurities-risk-serious-injury · Updated August 17, 2026 · FDA enforcement record: FDA #D-0543-2024

Cite this page

“Zydus Estradiol Transdermal System Recall: Impurities Risk Serious Injury.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32665-zydus-estradiol-transdermal-system-recall-impurities-risk-serious-injury. Based on FDA recall #D-0543-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0543-2024%22&limit=1).

The FDA announced on May 16, 2024, that Zydus Pharmaceuticals (USA) Inc is recalling Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day due to failed impurities and degradation specifications. The recall affects 13,440 units distributed nationwide.

How to tell if you have it

Brand: Zydus Pharmaceuticals
Product: Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day
NDC: 70710-1191-8
Lot #: M311202, Exp. Date 2/25
Lot #: M311201, Exp. Date 1/25

The hazard

The product failed impurities and degradation specifications. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Zydus Pharmaceuticals (USA) Inc has 53 other recalls on record since 2012-03-14. Other recent recalls of similar products include Zydus Mirabegron 25mg Tablets Recall (2026-08-05), Zydus Erythromycin Tablets Recall (2026-04-29), and Zydus Recalls Icosapent Ethyl Capsules Due to Defects (2026-03-09). Other recent recalls of similar products include Teva Clonidine Transdermal System Recall (2026-03-19), Novadoz Glycopyrrolate Oral Solution Recall (2025-12-15), and Sagent Busulfan Injection Recall (2026-05-04).

How to tell if you have this one

Check the product label for the lot number (M311201 or M311202) and expiration date (January 25 or February 25). This estradiol patch is only available by prescription.

Brand
Zydus Pharmaceuticals
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Ongoing
Distribution
Nationwide within the United States
NDC
70710-1191-1, 70710-1191-8, 70710-1192-1, 70710-1192-8, 70710-1193-1, 70710-1193-8, 70710-1194-1, 70710-1194-8, 70710-1195-1, 70710-1195-8

Recall number	Product, codes & lots	Quantity
D-0542-2024	Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8; 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	21,360 units
D-0543-2024	Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8; Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25	13,440 units

Based on the official FDA remedy

What to do — step by step

Stop Using Now
Immediately stop using the estradiol transdermal system if you have the recalled lot numbers.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 27 days after the firm started it.

May 16, 2024Firm started the recall
Jun 6, 2024FDA classified it Class III
Jun 12, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have this product?

Stop using it immediately and contact your doctor for alternative treatment options.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/32665-zydus-estradiol-transdermal-system-recall-impurities-risk-serious-injury">Zydus Estradiol Transdermal System Recall: Impurities Risk Serious Injury (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #D-0543-2024 (May 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0543-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.