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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94649

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 16, 2024
Product types
Drug
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Zydus Pharmaceuticals (USA) Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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

D-0542-2024
Recall number
D-0542-2024
Initiated
May 16, 2024
Classification
Class III
Status
Ongoing
Quantity
21,360 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications.

Code information

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

Distribution pattern

Nationwide within the United States

drug · product 2 of 2

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

D-0543-2024
Recall number
D-0543-2024
Initiated
May 16, 2024
Classification
Class III
Status
Ongoing
Quantity
13,440 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications.

Code information

Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25

Distribution pattern

Nationwide within the United States