Minivelle — Class II drug recall D-0485-2015
Terminated recall by Noven Pharmaceuticals, Inc., reported 2015-04-22, distributed nationwide. Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
| Recall number | D-0485-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noven Pharmaceuticals, Inc., Miami, FL, United States |
| Recall initiated | 2015-02-25 |
| Classified | 2015-04-13 |
| Reported by FDA | 2015-04-22 |
| Terminated | 2019-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 720 transdermal |
| Reason classes | labeling, temperature control |
| 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 | 07/16, 76476 |
Product
Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 33186, Distributed by Noven Pharmaceuticals, LLC, Miami, Florida 33186, NDC 68968-6650-8
Reason for recall
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
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-0485-2015. 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.