Viatris recalls

Viatris appears in 25 official U.S. recall notices indexed by RecallRadar, most recently on 2026-04-15.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06…
  FDA Drug · Class II · 2026-04-15 · Viatris
  Reason: Failed Dissolution Specifications
• Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505…
  FDA Drug · Class II · 2025-01-22 · Viatris
  Reason: Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
• Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505,…
  FDA Drug · Class II · 2025-01-22 · Viatris
  Reason: Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
• Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10),…
  FDA Drug · Class II · 2024-12-18 · Viatris
  Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
• Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10),…
  FDA Drug · Class II · 2024-12-18 · Viatris
  Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
• Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10),…
  FDA Drug · Class II · 2024-12-18 · Viatris
  Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
• Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10),…
  FDA Drug · Class II · 2024-12-18 · Viatris
  Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
• Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10),…
  FDA Drug · Class II · 2024-12-18 · Viatris
  Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
• Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10),…
  FDA Drug · Class II · 2024-12-18 · Viatris
  Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
• Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10),…
  FDA Drug · Class II · 2024-12-18 · Viatris
  Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
• Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10),…
  FDA Drug · Class II · 2024-12-18 · Viatris
  Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
• Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10),…
  FDA Drug · Class II · 2024-12-18 · Viatris
  Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
• Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10),…
  FDA Drug · Class II · 2024-12-18 · Viatris
  Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
• Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10),…
  FDA Drug · Class II · 2024-12-18 · Viatris
  Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
• Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer…
  FDA Drug · Class II · 2024-07-24 · Viatris
  Reason: Failed Impurities/Degradation Specifications
• Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer…
  FDA Drug · Class II · 2024-07-24 · Viatris
  Reason: Failed Impurities/Degradation Specifications
• Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc
  FDA Drug · Class III · 2024-05-08 · Viatris
  Reason: Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
• Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distr…
  FDA Drug · Class II · 2023-06-14 · Viatris
  Reason: 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.
• Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc
  FDA Drug · Class II · 2022-11-23 · Viatris
  Reason: Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
• Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufact…
  FDA Drug · Class I · 2022-11-16 · Viatris
  Reason: Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
• Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, Rx only, Mylan Manufa…
  FDA Drug · Class II · 2022-10-05 · Viatris
  Reason: Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
• Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc…
  FDA Drug · Class II · 2022-05-18 · Viatris
  Reason: Failed Dissolution Specifications: low out of specification results for dissolution.
• alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1
  FDA Drug · Class II · 2022-05-11 · Viatris
  Reason: Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
• Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY,…
  FDA Drug · Class II · 2021-10-06 · Viatris
  Reason: Failed Dissolution Specifications
• Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-323…
  FDA Drug · Class III · 2021-09-22 · Viatris
  Reason: Failed Impurities/Degradation Specifications; out of specification for Related Compound