Home / Recalls / Alvogen, Inc / D-0245-2025

D-0245-2025 Class I Ongoing

Recalled by Alvogen, Inc — Morristown, NJ

Recall Details

Product Type
Drugs
Report Date
February 26, 2025
Initiation Date
January 31, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
112,128 cartons (5 pouches/carton)

Product Description

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.

Reason for Recall

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

Distribution Pattern

USA Nationwide

Code Information

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

Other recalls by Alvogen, Inc

  • D-0259-2026 Class II — Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Ma (December 31, 2025)
  • D-0353-2023 Class II — Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manuf (February 6, 2023)
  • D-0649-2021 Class II — Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing (February 26, 2021)
  • D-1722-2019 Class II — Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx (July 24, 2019)
  • D-1723-2019 Class II — Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. b (July 24, 2019)
  • D-1277-2019 Class I — FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx on (April 19, 2019)
  • D-0939-2017 Class II — Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE (June 16, 2017)
  • D-0941-2017 Class II — Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE (June 16, 2017)
  • D-0940-2017 Class II — Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE (June 16, 2017)
  • D-0633-2017 Class III — Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx On (March 7, 2017)