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Endo Pharmaceuticals, Inc.

Complete recall history across all FDA and CPSC categories — 5 total recalls

Endo Pharmaceuticals, 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 (5)

FDA drug safety enforcement actions by Endo Pharmaceuticals, Inc.

Date Product Reason Class
Jul 10, 2024 Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per ... Labeling: Label Error on Declared Strength; Some cartons were incorrectly lab... Class I
Mar 2, 2023 Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL correspon... Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of ... Class II
Sep 17, 2018 robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, ... Labeling: Incorrect Instructions: Dosage information on the immediate contain... Class I
Feb 22, 2017 Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only,... Lack of Assurance of Sterility: Defective container resulting in the lack of ... Class II
May 7, 2012 Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count t... Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet... Class III

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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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