Minivelle — Class II drug recall D-0863-2018
Terminated recall by Noven Pharmaceuticals, Inc., reported 2018-05-16, distributed nationwide. Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive p
| Recall number | D-0863-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noven Pharmaceuticals, Inc., Miami, FL, United States |
| Recall initiated | 2018-05-04 |
| Classified | 2018-06-13 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 70,870 boxes |
| NDC | 68968-6610, 68968-6610-08, 68968-6625, 68968-6625-08, 68968-6637, 68968-6637-01, 68968-6637-08, 68968-6650, 68968-6650-08, 68968-6675, 68968-6675-08 |
| Lot numbers | 03/19, 12/18, 81896, 82264 |
Product
Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
Reason for recall
Defective Delivery System: no longer meets the specification for 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-0863-2018. 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.