Aidarex Pharmaceuticals LLC

Complete recall history across all FDA and CPSC categories — 10 total recalls

Aidarex Pharmaceuticals LLC 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 (10)

FDA drug safety enforcement actions by Aidarex Pharmaceuticals LLC

Date Product Reason Class
Jun 27, 2018 Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Ph... Out-of-specification results for the Enalapril Diketopiperazine degradation p... Class III
Jun 27, 2018 Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex ... Out-of-specification results for the Enalapril Diketopiperazine degradation p... Class III
Jun 27, 2018 Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Ph... Out-of-specification results for the Enalapril Diketopiperazine degradation p... Class III
Apr 10, 2018 Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 Presence of Foreign Tablets/Capsules Class III
Sep 5, 2017 ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhard... Failed Impurities/Degradation Specifications: manufacturer of product recalle... Class III
Sep 5, 2017 Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aid... Failed Impurities/Degradation Specification; out-of-specification results for... Class III
Jun 1, 2016 CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. ... Failed Impurity/Degradation Specifications: Out of specifications for unknown... Class II
Jun 1, 2016 Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, ... Failed Impurities/Degradation Specifications: Out of specification results fo... Class III
Jun 1, 2016 CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA,... CGMP Deviations: Out of specification (OOS) intermediate in the subsequent pr... Class III
May 22, 2014 Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex P... Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in... 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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