Alvogen, Inc recalls

10 recalls in our records from 2014 to 2026: 10 FDA drugs.

Recalls with full detail pages

• FDA · DrugsClass IFeb 26, 2025

  Alvogen, Inc drug recall: Fentanyl Transdermal System CII

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

Earlier and other recalls

These link to the official agency notice.

• FDA · DrugsClass IIJan 21, 2026

  Alvogen, Inc drug recall: Levothyroxine Sodium Tablets Official notice ↗

  Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.

• FDA · DrugsClass IIMar 8, 2023

  Alvogen, Inc drug recall: Levothyroxine Sodium Tablets Official notice ↗

  Sub-Potent Drug: Out of specification for assay at the 24 month interval.

• FDA · DrugsClass IIJul 14, 2021

  Alvogen, Inc drug recall: Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg Official notice ↗

  Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)

• FDA · DrugsClass IIAug 21, 2019

  Alvogen, Inc drug recall: Nitrofurantoin Monohydrate/Macrycrystals Capsules Official notice ↗

  Failed dissolution specifications

• FDA · DrugsClass IMay 15, 2019

  Alvogen, Inc drug recall: FENTANYL Transdermal System Official notice ↗

  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.

• FDA · DrugsClass IIJul 12, 2017

  Alvogen, Inc drug recall: Clindamycin Injection USP Official notice ↗

  Lack of Assurance of Sterility

• FDA · DrugsClass IIIApr 12, 2017

  Alvogen, Inc drug recall: Nifedipine Extended-Release Tablets Official notice ↗

  Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

• FDA · DrugsClass IIMay 20, 2015

  Alvogen, Inc drug recall: Nitrofurantoin Monohydrate/Macrocrystals Capsules Official notice ↗

  Failed Dissolution Specification; 6 month time point

• FDA · DrugsClass IIOct 1, 2014

  Alvogen, Inc drug recall: Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count… Official notice ↗

  Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone…

Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.