# FDA recall D-0725-2021

> **Noven Pharmaceuticals Inc** · Class II · drug recall initiated 2021-07-30.

## Product

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

## Reason for recall

Failed Stability Specifications; out of specification for shear.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0725-2021
- **Recalling firm:** Noven Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2021-07-30
- **Report date:** 2021-08-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0725-2021

## Citation

> AI Analytics. FDA recall D-0725-2021. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0725-2021. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*