CLASS I ONGOING Drug recall · Reported 26 Feb 2025 · FDA Enforcement Report
Fentanyl Transdermal System CII, 25mcg/h recalled by Alvogen
Alvogen is recalling Fentanyl Transdermal System CII, 25mcg/h, distributed nationwide in the US. The recall was initiated on 31 Jan 2025 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0245-2025
- FDA event ID
- 96222
- Recalling firm
- Alvogen, Morristown, NJ
- Brand
- Fentanyl System
- Manufacturer
- ALVOGEN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 31 Jan 2025
- FDA classified
- 20 Feb 2025
- Reported
- 26 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 31 Jan 2025 | Recall initiated by company | |
| 20 Feb 2025 | Classified by FDA | +20 days |
| 26 Feb 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Which lots are affected?
Lot #: 108319, Exp: 04/30/2027
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Alvogen
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg recalled | Alvogen | Packaging Defects | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP 112 mcg recalled by Alvogen | Alvogen | Potency & Assay | Nationwide |
| Drug | CLASS II | Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg recalled by AlvogenBuprenorphine And Naloxone | Alvogen | Potency & Assay | Nationwide |
| Drug | CLASS II | Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg recalledNitrofurantoin Monohydrate/ Macrocrystalline | Alvogen | Potency & Assay | PR |
| Drug | CLASS II | Macrobid Urinary Tract Anitbacterial, 100 mg recalled by AlvogenMacrobid | Alvogen | Potency & Assay | PR |
Other Fentanyl recalls
All 248| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL Citrate, 1,000 mcg recalled by OurPharma | OurPharma | Other | Nationwide |
| Drug | CLASS II | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled | IntegraDose Compounding Services | Potency & Assay | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution recalled by Wells Pharma of Houston | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, CII recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |