Reported Jul 14, 2021 · Terminated

Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by:…

Alvogen, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alvogen, Inc · 44 Whippany Rd Ste 107 · Morristown, NJ · 07960-4558

Is this the product you have?

  • Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film
  • Distributed byAlvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03
Lot codes and dates
    • Lot #: 36924
    • Exp 6/2021
Amount recalled
9,696 cartons

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 16, 2022 · Data as of Sep 19, 6:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.