Alvogen, Inc

Complete recall history across all FDA and CPSC categories — 21 total recalls

Alvogen, Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (21)

FDA drug safety enforcement actions by Alvogen, Inc

Date Product Reason Class
Dec 31, 2025 Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only,... Product Mix-Up: A single bottle of this lot was reported by a pharmacy to con... Class II
Jan 31, 2025 Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packag... Defective delivery system - patches could be multi-stacked, adhered one on to... Class I
Feb 6, 2023 Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Ma... Sub-Potent Drug: Out of specification for assay at the 24 month interval. Class II
Feb 26, 2021 Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each contain... Subpotent drug: Out of specification for assay of naloxone and buprenorphine ... Class II
Jul 24, 2019 Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, ... Failed dissolution specifications Class II
Jul 24, 2019 Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg... Failed dissolution specifications Class II
Apr 19, 2019 FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx... Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Tran... Class I
Jun 16, 2017 Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANT... Lack of Assurance of Sterility Class II
Jun 16, 2017 Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANT... Lack of Assurance of Sterility Class II
Jun 16, 2017 Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANT... Lack of Assurance of Sterility Class II
Mar 7, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx... Cross Contamination with another product:residual powder found in inlet air d... Class III
Mar 7, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx... Cross Contamination with another product:residual powder found in inlet air d... Class III
Mar 7, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx... Cross Contamination with another product:residual powder found in inlet air d... Class III
Mar 7, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx... Cross Contamination with another product:residual powder found in inlet air d... Class III
Mar 7, 2017 Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manuf... Cross Contamination with another product:residual powder found in inlet air d... Class III
Mar 7, 2017 Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, ... Cross Contamination with another product:residual powder found in inlet air d... Class III
Mar 7, 2017 Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx ... Cross Contamination with another product:residual powder found in inlet air d... Class III
Mar 7, 2017 Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manuf... Cross Contamination with another product:residual powder found in inlet air d... Class III
Mar 7, 2017 Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manuf... Cross Contamination with another product:residual powder found in inlet air d... Class III
Apr 21, 2015 NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, ... Failed Dissolution Specification; 6 month time point Class II
Aug 28, 2014 Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Onl... Failed Content Uniformity Specifications - The lot failed to meet the accepta... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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