Viatris Inc
Complete recall history across all FDA and CPSC categories — 22 total recalls
Viatris 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 (22)
FDA drug safety enforcement actions by Viatris Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 23, 2024 | Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx on... | Failed Impurities/Degradation Specifications: Out of specification results ob... | Class II |
| Dec 23, 2024 | Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx onl... | Failed Impurities/Degradation Specifications: Out of specification results ob... | Class II |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (ND... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (ND... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (ND... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (ND... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II |
| Apr 30, 2024 | Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Onl... | Failed Impurities/Degradation Specifications | Class II |
| Apr 30, 2024 | Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Onl... | Failed Impurities/Degradation Specifications | Class II |
| Apr 25, 2024 | Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for... | Failed Tablet/Capsule Specifications: There is a potential for the imprint, M... | Class III |
| May 25, 2023 | Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water... | CGMP Deviations: Discontinuation of the Quality program by manufacturer that ... | Class II |
| Oct 21, 2022 | Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharma... | Failed Tablet/Capsule Specifications: Tablets exceeds specification for weigh... | Class II |
| Oct 7, 2022 | Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Sy... | Presence of Particulate Matter: Product complaint for the presence of glass p... | Class I |
| Sep 21, 2022 | Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 ... | Presence of Particulate Matter: A complaint was received for the presence of ... | Class II |
| Apr 28, 2022 | Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx onl... | Failed Dissolution Specifications: low out of specification results for disso... | Class II |
| Apr 28, 2022 | alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distr... | Failed Dissolution Specifications: low out-of-specification dissolution test ... | 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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