Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg Recalled by Alvogen, Inc Due to Subpotent drug: Out of specification for assay of...

Date: February 26, 2021
Company: Alvogen, Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Alvogen, Inc directly.

Affected Products

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

Quantity: 9,696 cartons

Why Was This Recalled?

Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Alvogen, Inc

Alvogen, Inc has 21 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report