Minivelle — Class III drug recall D-0923-2017
Terminated recall by Noven Pharmaceuticals, Inc., reported 2017-07-05, distributed nationwide. Defective Delivery System: Out of specification for peel force from the release liner specification during sta
| Recall number | D-0923-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noven Pharmaceuticals, Inc., Miami, FL, United States |
| Recall initiated | 2017-04-27 |
| Classified | 2017-06-23 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2019-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 14,434 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 | 78618 |
| Expiration dates | 2017-05 |
Product
Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8
Reason for recall
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
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-0923-2017. 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.