CLASS I Drug recall · Reported 15 May 2019 · FDA Enforcement Report
Fentanyl Transdermal System, 12 mcg/h, five (12 mcg/h) systems recalled
Alvogen is recalling Fentanyl Transdermal System, 12 mcg/h, five (12 mcg/h) systems per, distributed nationwide in the US. The recall was initiated on 19 Apr 2019 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-1277-2019
- FDA event ID
- 82669
- Recalling firm
- Alvogen, Pine Brook, NJ
- Brand
- Fentanyl System
- Manufacturer
- ALVOGEN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Apr 2019
- FDA classified
- 13 May 2019
- Reported
- 15 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 19 Apr 2019 | Recall initiated by company | |
| 13 May 2019 | Classified by FDA | +24 days |
| 15 May 2019 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
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, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.
Where was it sold?
Nationwide in the USA
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 I | Fentanyl Transdermal System CII, 25mcg/h recalled by AlvogenFentanyl System | 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 |
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 |