# FDA recall D-0649-2021

> **Alvogen, Inc** · Class II · drug recall initiated 2021-02-26.

## 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)

## Distribution

USA nationwide.

## Key facts

- **Recall number:** D-0649-2021
- **Recalling firm:** Alvogen, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-02-26
- **Report date:** 2021-07-14
- **Termination date:** 2022-02-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morristown, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0649-2021

## Citation

> AI Analytics. FDA recall D-0649-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0649-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*