Use cautionDrug recall · FDA · Published January 31, 2025
Alvogen Fentanyl Patches: Risk of Overdose from Multi-Stacked Patches
Alvogen recalls Fentanyl transdermal patches that may be stacked incorrectly, increasing overdose risk. Affected units were distributed with specific lot numbers and expiration dates.
“Alvogen Fentanyl Patches: Risk of Overdose from Multi-Stacked Patches.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32300-alvogen-fentanyl-patches-risk-of-overdose-from-multi-stacked-patches. Based on FDA recall #D-0245-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0245-2025%22&limit=1).
The FDA announced on Jan. 31, 2025, that Alvogen, Inc. is recalling Fentanyl Transdermal System CII, 25mcg/h patches due to a defective delivery system that could allow patches to be multi-stacked in a single pouch. The recall affects 112,128 cartons distributed nationwide.
How to tell if you have it
Brand: Alvogen
Product: Fentanyl Transdermal System CII, 25mcg/h
Packaging: Pouch in 5-count carton
NDC: 47781-424-47
Lot #: 108319
Expiration: 04/30/2027
Distribution: USA Nationwide
The hazard
The patches could be multi-stacked, adhered one on top of the other, in a single product pouch. The FDA classified this as a Class I recall.
Context
GovInfoNow's records show Alvogen, Inc. has 9 other recalls on record since 2014-08-28. Other recent recalls of similar products include IntegraDose Fentanyl Citrate Recall (2026-05-12), Aveva Nicotine Patch Recall (2026-05-14), and Mallinckrodt Acthar Gel 5mL Vial Recall (2026-08-06).
How to tell if you have this one
Check for Fentanyl transdermal patches (25mcg/h) in a pouch inside a 5-count carton. The lot number is 108319 with an expiration date of April 30, 2027.
Brand
Alvogen
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot number 108319 on the packaging with an expiration date of April 30, 2027.
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 published this recall 26 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
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-0245-2025 (January 31, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0245-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.