Combipatch — Class II drug recall D-0724-2021
Ongoing recall by Noven Pharmaceuticals Inc, reported 2021-08-25, distributed nationwide. Failed Stability Specifications; out of specification for shear.
| Recall number | D-0724-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noven Pharmaceuticals Inc, Miami, FL, United States |
| Recall initiated | 2021-07-30 |
| Classified | 2021-08-13 |
| Reported by FDA | 2021-08-25 |
| Distributed | Nationwide (US) |
| Quantity | 223,382 boxes |
| Reason classes | specification failure |
| NDC | 68968-0514, 68968-0514-02, 68968-0514-08, 68968-0525, 68968-0525-08 |
| Lot numbers | 88227, 88542, 88696, 89357 |
| Expiration dates | 2021-12, 2022-03, 2022-05, 2022-08 |
Product
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0724-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.