CLASS II ONGOING Drug recall · Reported 25 Aug 2021 · FDA Enforcement Report
Combipatch (estradiol/norethindrone acetate transdermal recalled
Noven Pharmaceuticals is recalling Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day, distributed nationwide in the US. The recall was initiated on 30 Jul 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0725-2021
- FDA event ID
- 88342
- Recalling firm
- Noven Pharmaceuticals, Miami, FL
- Manufacturer
- Noven Therapeutics, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jul 2021
- FDA classified
- 13 Aug 2021
- Reported
- 25 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 30 Jul 2021 | Recall initiated by company | |
| 13 Aug 2021 | Classified by FDA | +14 days |
| 25 Aug 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications; out of specification for shear.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Failed Stability Specifications; out of specification for shear.
Which lots are affected?
Lots: 88540 Exp. 03/2022; 89118 Exp. 05/2022; 89244 Exp. 07/2022; 89244 (sample lot) Exp. 07/2022
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 88342This product is part of a recall event; the main page for the event is Combipatch (estradiol/norethindrone acetate transdermal recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Combipatch (estradiol/norethindrone acetate transdermal recalledCombipatch (estradiol/norethindrone Acetate Transdermal System) | Noven Pharmaceuticals | Potency & Assay | Nationwide |
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