Viatris Inc

FDA Regulatory Profile

Summary

Total Recalls
24 (1 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0204-2025Class IICardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by ViatDecember 23, 2024
D-0203-2025Class IICardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by ViatrDecember 23, 2024
D-0127-2025Class IILevothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b)November 18, 2024
D-0119-2025Class IILevothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b)November 18, 2024
D-0124-2025Class IILevothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) November 18, 2024
D-0128-2025Class IILevothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b)November 18, 2024
D-0123-2025Class IILevothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) November 18, 2024
D-0125-2025Class IILevothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) November 18, 2024
D-0126-2025Class IILevothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) November 18, 2024
D-0121-2025Class IILevothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b)November 18, 2024
D-0122-2025Class IILevothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b)November 18, 2024
D-0120-2025Class IILevothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b)November 18, 2024
D-0118-2025Class IILevothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b)November 18, 2024
D-0603-2024Class IICardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, DiApril 30, 2024
D-0602-2024Class IICardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, DApril 30, 2024
D-0481-2024Class IIIValacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan PharmaceuticalsApril 25, 2024
D-0866-2023Class IILevsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml AmMay 25, 2023
D-0063-2023Class IICarvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. MorgantoOctober 21, 2022
D-0058-2023Class IOctreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For SubcutaneouOctober 7, 2022
D-1542-2022Class IIAmpicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton September 21, 2022