FDA Drug recall D-0649-2021
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc
- FDA Drug
- Class II
- terminated
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class II recall of Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc by Alvogen, citing subpotent drug: Out of specification for assay of naloxone and buprenorphine (low).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0649-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-26 |
| Published | 2021-07-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Alvogen |
| Distribution | US |
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
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Identifiers
| ndc | 47781-355-11 |
|---|---|
| ndc | 47781-355-03 |
| ndc | 47781-356-11 |
| ndc | 47781-356-03 |
| ndc | 47781-357-11 |
| ndc | 47781-357-03 |
| ndc | 47781-358-11 |
| ndc | 47781-358-03 |
| code_info | Lot #: 36924, Exp 6/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0649-2021%22
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