Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
Drug Recall
Official source record
- Recall number
- D-0725-2021
- Event ID
- 88342
- Classification
- Class II
- Status
- Ongoing
- Recalling company
- Noven Pharmaceuticals Inc
- Reason for recall
- Failed Stability Specifications; out of specification for shear.
- Report date
- August 25, 2021
- Recall initiation date
- July 30, 2021
- Termination date
- Not terminated as of this source record
- Distribution pattern
- Nationwide.
Drug product identifiers
- Manufacturer
- Noven Therapeutics, LLC
- Brand name
- COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
- Generic name
- ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM
- Substance names
- ESTRADIOL; NORETHINDRONE ACETATE
- Product NDCs
- 68968-0514; 68968-0525
- Package NDCs
- 68968-0514-8; 68968-0525-2; 68968-0525-8
- Route
- TRANSDERMAL
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details, or FDA Enforcement Reports versus recall announcements for why that gap exists. New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.
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Frequently asked questions
What does a Class II mean?
FDA classifies this recall as Class II. See how to read an FDA recall record for what each classification level means.
Is this recall still active?
According to the FDA, this recall's status is "Ongoing." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
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Official guidance and record verification
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Compare the medication name, manufacturer, NDC, package information, and lot number on your medication with the official FDA record to see whether it matches.
Public Health Trace last retrieved this record on July 28, 2026.
Public Health Trace republishes FDA's drug recall record and does not provide medical or medication instructions -- review the official FDA record and FDA's general drug recall guidance (linked below) for what to do.
View the official FDA record · General drug recall guidance from FDA
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.