Viatris Inc
18 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Viatris Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-15FDA-DrugClass IICheck your Xanax XR 3 mg prescription bottle
Failed Dissolution Specifications
- 2025-01-22FDA-DrugClass IICardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
- 2025-01-22FDA-DrugClass IICardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
- 2024-12-18FDA-DrugClass IILevothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
- 2024-12-18FDA-DrugClass IILevothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
- 2024-12-18FDA-DrugClass IILevothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
- 2024-12-18FDA-DrugClass IILevothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
- 2024-12-18FDA-DrugClass IILevothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
- 2024-12-18FDA-DrugClass IILevothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
- 2024-12-18FDA-DrugClass IILevothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
- 2024-12-18FDA-DrugClass IILevothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
- 2024-12-18FDA-DrugClass IILevothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
- 2024-12-18FDA-DrugClass IILevothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
- 2024-12-18FDA-DrugClass IILevothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
- 2024-07-24FDA-DrugClass IICardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10
Failed Impurities/Degradation Specifications
- 2024-07-24FDA-DrugClass IICardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10
Failed Impurities/Degradation Specifications
- 2024-05-08FDA-DrugClass IIIValacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
- 2023-06-14FDA-DrugClass IILevsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
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