Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Complete recall history across all FDA and CPSC categories — 22 total recalls

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 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 (22)

FDA drug safety enforcement actions by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Date Product Reason Class
Apr 1, 2022 Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit ... Failed Impurities/Degradation Specifications: OOS result was obtained for Any... Class II
Apr 1, 2022 Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit ... Failed Impurities/Degradation Specifications: OOS result was obtained for Any... Class II
Jan 18, 2019 Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for... Failed Impurities/Degradation Specifications: Elevated levels of a known imp... Class II
Aug 14, 2018 Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister c... Failed Impurities/Degradation Specifications; out of specification results fo... Class III
May 1, 2018 Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Ma... GMP Deviations: a recent FDA inspection of the manufacturing site revealed mu... Class II
May 1, 2018 Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Ma... GMP Deviations: a recent FDA inspection of the manufacturing site revealed mu... Class II
Mar 21, 2017 Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) p... Microbial Contamination of Non-Sterile Products: potential of an elevated bio... Class II
Jan 27, 2017 Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactur... Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets ... Class II
Sep 28, 2016 Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10... Failed Impurities/Degradation Specifications: out of specification result for... Class III
Sep 28, 2016 Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10... Failed Impurities/Degradation Specifications: out of specification result for... Class III
Jan 28, 2016 Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by M... Failed Impurities/Degradation Specifications: out of specification result for... Class III
Nov 2, 2015 Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tabl... Failed Impurities/Degradation Specifications: Out of specification for impuri... Class III
Mar 26, 2015 Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihista... Failed Impurities/Degradation Specifications: the manufacturer, recalled prod... Class III
Jul 3, 2014 Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules... Failed Impurities/Degradation Specifications: High out-of-specification resul... Class III
Jan 28, 2014 Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets ... Failed Impurity/degradation Specification Class III
Sep 26, 2013 LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 bl... CGMP Deviations: Pharmaceuticals were produced and distributed with active in... Class II
Sep 26, 2013 CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card.... CGMP Deviations: Pharmaceuticals were produced and distributed with active in... Class II
Sep 17, 2013 Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) ... CGMP Deviations: Pharmaceuticals were produced and distributed with active in... Class II
Sep 17, 2013 Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) ... CGMP Deviations: Pharmaceuticals were produced and distributed with active in... Class II
Sep 17, 2013 Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) u... CGMP Deviations: Pharmaceuticals were produced and distributed with active in... Class II
May 15, 2013 Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit... Failed Dissolution Specifications: Routine stability testing at the 12-month ... Class III
Dec 14, 2012 Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tabl... Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superp... Class I

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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