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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96222

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 31, 2025
Product types
Drug
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Alvogen, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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.

D-0245-2025
Recall number
D-0245-2025
Initiated
January 31, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Alvogen, Inc
Quantity
112,128 cartons (5 pouches/carton)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.

Code information

Lot #: 108319, Exp: 04/30/2027

Distribution pattern

USA Nationwide

Field note

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