Buprenorphine Transdermal System 5 mcg/hour — Class II drug recall D-0003-2021
Terminated recall by Teva Pharmaceuticals USA, reported 2020-10-07, distributed nationwide. Failed Stability Specifications: Below specification result for buprenorphine release rate.
| Recall number | D-0003-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2020-09-04 |
| Classified | 2020-10-01 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2021-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 32,543 cartons |
| Reason classes | specification failure |
| NDC | 00093-3239, 00093-3239-40, 00093-3656, 00093-3656-21, 00093-3656-40, 00093-3657, 00093-3657-40, 00093-3658, 00093-3658-40, 00093-3659, 00093-3659-40 |
| Lot numbers | 190017, 190161 |
| Expiration dates | 2021-02, 2021-08 |
Product
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva Pharmaceuticals USA Inc., North Wales, PA 19454, carton NDC: 0093-3656-40, patch NDC: 0093-3656-21.
Reason for recall
Failed Stability Specifications: Below specification result for buprenorphine release rate.
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-0003-2021. 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.