The Recall Desk
SevereFDA (Drugs)·D-0649-2021·Announced 2021-07-14

Alvogen Buprenorphine and Naloxone Sublingual Film recalled for subpotent active ingredients

Alvogen, Inc. is recalling Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg due to out-of-specification assay results showing low levels of both naloxone and buprenorphine.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of a prescription drug affecting therapeutic efficacy. Subpotent active pharmaceutical ingredients in a critical medication (buprenorphine/naloxone used for pain management and opioid use disorder treatment) present significant risk of treatment failure and patient harm, meeting the Severe threshold for Class II recalls with potential for serious clinical consequences.

Plain-English summary

Alvogen, Inc. is recalling Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg nationwide. The affected product is distributed in 30-pouch cartons containing sublingual films (NDC 47781-355-03). Lot #36924 with expiration date 6/2021 has been identified as failing assay testing, with results showing out-of-specification levels of both naloxone and buprenorphine below the labeled amounts.

A total of 9,696 cartons have been distributed nationwide. Subpotent active ingredients may result in inadequate therapeutic efficacy, potentially compromising pain management and opioid use disorder treatment in affected patients.

Consumers and healthcare providers with this product should stop dispensing or using it and contact Alvogen, Inc. for further instructions. For more information, patients should consult their healthcare provider or pharmacist.

The recalled product

Product
BUPRENORPHINE AND NALOXONE (BUPRENORPHINE AND NALOXONE)
Brand
BUPRENORPHINE AND NALOXONE
Manufacturer
Alvogen, Inc
Category
Drug — Opioid/Opioid Use Disorder Treatment
Hazard
  • subpotent-active-ingredient
  • inadequate-therapeutic-efficacy

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 36924
  • Exp 6/2021

UPCs (8)

  • 0347781356118
  • 0347781358037
  • 0347781355036
  • 0347781357030
  • 0347781356033
  • 0347781358112
  • 0347781357115
  • 0347781355111

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · BUPRENORPHINE AND NALOXONE

Same category