Mylan Institutional, Inc.

Complete recall history across all FDA and CPSC categories — 8 total recalls

Mylan Institutional, 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 (8)

FDA drug safety enforcement actions by Mylan Institutional, Inc.

Date Product Reason Class
Mar 7, 2025 Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose ... Super-Potent Drug: Out of specification potency results were obtained. Class II
Mar 7, 2025 Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose... Super-Potent Drug: Out of specification potency results were obtained. Class II
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (... Subpotent and Superpotent Drug Class II
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton... Subpotent and Superpotent Drug 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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