Minivelle — Class II drug recall D-1209-2018
Terminated recall by Noven Pharmaceuticals, Inc., reported 2018-10-03, distributed nationwide. Defective Delivery System: out of specification results for shear, an attribute related to the adhesive proper
| Recall number | D-1209-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noven Pharmaceuticals, Inc., Miami, FL, United States |
| Recall initiated | 2018-09-07 |
| Classified | 2018-09-25 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2020-09-09 |
| Distributed | Nationwide (US) |
| 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 | 82199, 83025 |
| Expiration dates | 2018-12, 2019-05 |
Product
Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8
Reason for recall
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
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-1209-2018. 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.