Highest risk U.S. Food and Drug Administration

Alvogen Fentanyl Transdermal System 25 mcg/h transdermal patches recall: There is potential that patches could be multi-stacked

Recall published 1+ years ago

There is potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch

Alvogen Prescription & OTC drugs — recalled prescription & otc drugsAlvogen Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Alvogen Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)
3 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Drug safety concern

A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

What the notice says: There is a possibility that the application of a multi-stacked 25 mcg/h patch could result in serious, life threatening, or fatal respiratory depression.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Published
January 31, 2025
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Alvogen
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Fentanyl Transdermal System 25 mcg/h transdermal patches

What the company announced

FOR IMMEDIATE RELEASE – January 31, 2025 – Morristown, NJ

Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal system is manufactured by Kindeva Drug Delivery L.P., Northridge, CA and is distributed by Alvogen, Inc. as a private label distributor.

There is a possibility that the application of a multi-stacked 25 mcg/h patch could result in serious, life threatening, or fatal respiratory depression. Groups at potential increased risk could include first-time recipients of such patches, children, and the elderly. To date, Alvogen has received one serious adverse event related to this recall.

The product is indicated for the management of severe and persistent pain in opioid-tolerant patients, that requires an extended treatment period with a daily opioid analgesic in opioid-tolerant patients, and for which alternative treatment options are inadequate, and is packaged in primary cartons of five individually wrapped and labeled pouches. The affected Fentanyl Transdermal System lot is:

Lot 108319 of Fentanyl Transdermal System, 25 mcg/h, expiration date 04/2027.

This lot of Fentanyl Transdermal System was distributed nationwide to the pharmacy and patient level. See image examples for lot 108319 and a multi-stacked patch.

Alvogen, Inc. is notifying its distributors and direct customers by certified letter and is arranging for return and replacement of all recalled products. Pharmacies are requested not to dispense any product subject to this recall.

Patients that have product subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused product should return it to point of purchase for replacement. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Questions regarding this recall should be directed to Alvogen Customer Complaints by calling 866-770-3024 or sending an e-mail to [email protected] , Monday to Friday from 9:00 am to 5:00 pm EST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 108319
  • 25

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 04/2027

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Alvogen — A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

  1. Check the lot number on your pack against the codes listed above.
  2. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  3. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  4. Keep the carton; the lot number is often printed only on the outer pack.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Remedy named in the notice: Alvogen, Inc. is notifying its distributors and direct customers by certified letter and is arranging for return and replacement of all recalled products.

Company contact: Alvogen, Inc. — Consumers: Alvogen Customer Complaints, 866-770-3024, [email protected] — Media: [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Alvogen prescription & otc drugs recalled?

There is potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch There is a possibility that the application of a multi-stacked 25 mcg/h patch could result in serious, life threatening, or fatal respiratory depression.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 108319, 25; best-by date 04/2027. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

The notice says: Alvogen, Inc. is notifying its distributors and direct customers by certified letter and is arranging for return and replacement of all recalled products.

Where was the recalled product sold?

It was distributed nationwide.

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