Fentanyl Transdermal System CII recall
FDA recall D-0245-2025 · initiated Jan 31, 2025
Alvogen, Inc recalled Fentanyl Transdermal System CII in Jan 2025 — an FDA Class I recall (D-0245-2025) because Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Another quality failure
A quality failure that does not fit the categories above.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 112,128 cartons (5 pouches/carton)
Details
- Product
- Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.
- Recalling company
- Alvogen Inc
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Jan 31, 2025
- FDA report date
- Feb 26, 2025
Frequently asked
- Was Fentanyl Transdermal System CII recalled?
- Alvogen, Inc recalled Fentanyl Transdermal System CII in Jan 2025 — an FDA Class I recall (D-0245-2025) because Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Fentanyl Transdermal System CII recalled?
- Per the FDA enforcement record, the reason for recall D-0245-2025 was: Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
- Is a recalled Fentanyl Transdermal System CII dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fentanyl Transdermal System CII are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #: 108319, Exp: 04/30/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0245-2025.