UnratedDrug recall · FDA · Published April 19, 2019
Alvogen Fentanyl Transdermal System 12mcg/h Recall: Product Mix-Up Risk
Alvogen recalls 12mcg/h Fentanyl patches due to mix-up with higher-dose 50mcg/h patches. Affected units contain 5 patches per carton labeled 12mcg/h but contain 50mcg/h patches. No remedy specified in recall notice.
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Take action
Contact the company
📍Recalling firmAlvogen, Inc10 Bloomfield Ave Bldg B Ste 2 · Pine Brook, NJ 07058-9743
“Alvogen Fentanyl Transdermal System 12mcg/h Recall: Product Mix-Up Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38896-alvogen-fentanyl-transdermal-system-12mcg-h-recall-product-mix-up. Based on FDA recall #D-1277-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1277-2019%22&limit=1).
The FDA announced on April 19, 2019, that Alvogen, Inc. voluntarily recalled Fentanyl Transdermal Systems, 12 mcg/h, due to a product mix-up hazard. The agency reported that cartons labeled with the lower dosage contained patches of the higher 50 mcg/h strength.
How to tell if you have it
Brand: Alvogen
Product: FENTANYL Transdermal System, 12 mcg/h
Quantity: Five (12 mcg/h) systems per carton
NDC: 47781-423-47
Lot codes: 180060 (Exp 05/2020), 180073 (Exp 06/2020)
Manufacturer: 3M Drug Delivery Systems, St. Paul, MN 55107
Distributor: Alvogen, Inc., Pine Brook, NJ 07058
Units affected: 119,608 cartons
Distribution: Nationwide in the USA
The hazard
The recall addresses a product mix-up where customer complaints indicated that cartons labeled as containing Fentanyl Transdermal Systems, 12 mcg/h actually contained five patches labeled and filled with 50 mcg/h. The FDA classified this error as a Class I recall, the most serious category.
Context
GovInfoNow's records show Alvogen, Inc. has issued nine other recalls since August 28, 2014. Recent similar recalls include an Alvogen Thyro-Tabs 150mcg Tablets recall on December 31, 2025, for product mix-up risk, and an Alvogen Fentanyl Patches recall on January 31, 2025, involving defective delivery systems. Other recent recalls of similar products include a Teva Clonidine Transdermal System recall on March 19, 2026, for unapproved raw material risk and Wells Pharma Fentanyl Citrate recalls on April 1, 2026, for cGMP deviations.
How to tell if you have this one
Check if your carton is labeled as 'Fentanyl Transdermal Systems, 12 mcg/h' and contains five patches. The product was distributed by Alvogen, Inc. with specific lot numbers (180060, Exp 05/2020; 180073, Exp 06/2020).
Brand
Alvogen
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for cartons labeled 'Fentanyl Transdermal Systems, 12 mcg/h' with five patches that contain 50 mcg/h doses.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
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-1277-2019 (April 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1277-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.