Lower riskDrug recall · FDA · Published February 26, 2021
Alvogen Buprenorphine Naloxone Film Recall: Subpotent Drug Risk
Alvogen recalls Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg due to low drug potency. This may reduce effectiveness for addiction treatment. Check NDC 47781-355-03, Lot 36924, Exp 6/2021.
“Alvogen Buprenorphine Naloxone Film Recall: Subpotent Drug Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36499-alvogen-buprenorphine-naloxone-film-recall-subpotent-drug-risk. Based on FDA recall #D-0649-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0649-2021%22&limit=1).
The FDA announced on Feb. 26, 2021, that Alvogen, Inc. voluntarily recalled Buprenorphine and Naloxone Sublingual Film due to subpotent drug risks. The Class II recall affects 9,696 cartons distributed nationwide.
How to tell if you have it
Brand: Alvogen
Product: Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg
Package: 30 pouches each containing 1 sublingual film
NDC: 47781-355-03
Lot #: 36924
Expiration: 6/2021
The hazard
The drug is out of specification for the assay of naloxone and buprenorphine, resulting in low potency levels. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Alvogen, Inc. has 9 other recalls on record since Aug. 28, 2014. Recent similar product recalls include American Health Packaging Buprenorphine Tablets (Aug. 19, 2026), Gasco Isopropyl Alcohol 70% (May 29, 2026), and Par Health Buprenorphine Injection (June 12, 2026).
How to tell if you have this one
Check for the NDC code 47781-355-03 and lot number 36924 with an expiration date of June 2021 on the packaging.
Brand
Alvogen
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for NDC 47781-355-03 and lot number 36924 with expiration 6/2021 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0649-2021 (February 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0649-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.