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Viatris, Inc. FDA Recalls
23 recalls on file across drugs, 1 of them Class I and 12 still open. Matched by name to VTRS.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLCClass IIMar 17, 2026Failed Dissolution Specifications |
| Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, MoClass IIDec 23, 2024Failed Impurities/Degradation Specifications: Out of specifi |
| Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, MClass IIDec 23, 2024Failed Impurities/Degradation Specifications: Out of specifi |
| Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles Class IINov 18, 2024Superpotent Drug and Subpotent Drug: potency failures obtain |
| Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles Class IINov 18, 2024Superpotent Drug and Subpotent Drug: potency failures obtain |
| Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles Class IINov 18, 2024Superpotent Drug and Subpotent Drug: potency failures obtain |
| Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (Class IINov 18, 2024Superpotent Drug and Subpotent Drug: potency failures obtain |
| Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (Class IINov 18, 2024Superpotent Drug and Subpotent Drug: potency failures obtain |
| Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles Class IINov 18, 2024Superpotent Drug and Subpotent Drug: potency failures obtain |
| Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles Class IINov 18, 2024Superpotent Drug and Subpotent Drug: potency failures obtain |
| Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (Class IINov 18, 2024Superpotent Drug and Subpotent Drug: potency failures obtain |
| Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles Class IINov 18, 2024Superpotent Drug and Subpotent Drug: potency failures obtain |
| Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles Class IINov 18, 2024Superpotent Drug and Subpotent Drug: potency failures obtain |
| Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (Class IINov 18, 2024Superpotent Drug and Subpotent Drug: potency failures obtain |
| Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Class IIApr 30, 2024Failed Impurities/Degradation Specifications |
| Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by RoerigClass IIApr 30, 2024Failed Impurities/Degradation Specifications |
| Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WVClass IIIApr 25, 2024Failed Tablet/Capsule Specifications: There is a potential f |
| Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampulClass IIMay 25, 2023CGMP Deviations: Discontinuation of the Quality program by m |
| Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made iClass IIOct 21, 2022Failed Tablet/Capsule Specifications: Tablets exceeds specif |
| Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous UseClass IOct 7, 2022Presence of Particulate Matter: Product complaint for the pr |
| Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, RxClass IISep 21, 2022Presence of Particulate Matter: A complaint was received for |
| alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 079Class IIApr 28, 2022Failed Dissolution Specifications: low out-of-specification |
| Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, DiClass IIApr 28, 2022Failed Dissolution Specifications: low out of specification |