Minivelle — Class II drug recall D-0336-2021
Terminated recall by Noven Pharmaceuticals Inc, reported 2021-04-28, distributed nationwide. Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to th
| Recall number | D-0336-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noven Pharmaceuticals Inc, Miami, FL, United States |
| Recall initiated | 2021-04-16 |
| Classified | 2021-04-20 |
| Reported by FDA | 2021-04-28 |
| Terminated | 2024-10-11 |
| Distributed | Nationwide (US) |
| Quantity | 12,060 cartons |
| Reason classes | specification failure |
| NDC | 68968-6610, 68968-6610-08, 68968-6625, 68968-6625-08, 68968-6637, 68968-6637-08, 68968-6650, 68968-6650-08, 68968-6675, 68968-6675-08 |
| Lot numbers | 88584 |
| Expiration dates | 2022-03 |
Product
Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8
Reason for recall
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
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-0336-2021. 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.