Buprenorphine and Naloxone Sublingual Film 2mg/0 — Class II drug recall D-0649-2021
Terminated recall by Alvogen, Inc, reported 2021-07-14, distributed nationwide. Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
| Recall number | D-0649-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alvogen, Inc, Morristown, NJ, United States |
| Recall initiated | 2021-02-26 |
| Classified | 2021-07-02 |
| Reported by FDA | 2021-07-14 |
| Terminated | 2022-02-16 |
| Distributed | Nationwide (US) |
| Quantity | 9,696 cartons |
| Reason classes | potency, specification failure |
| NDC | 47781-0355, 47781-0355-03, 47781-0355-11, 47781-0356, 47781-0356-03, 47781-0356-11, 47781-0357, 47781-0357-03, 47781-0357-11, 47781-0358, 47781-0358-03, 47781-0358-11 |
| Lot numbers | 36924 |
| Expiration dates | 2021-06 |
Product
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03
Reason for recall
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
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-0649-2021. 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.