Canonsburg, PA, United States
Viatris Inc recalls
13 recalls recorded since 2018, most recently on 17 March 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls13
Ongoing (FDA)2
Terminated or completed11
Class I (FDA)1
Ongoing Class II Drugs
- Recall started
- 17 March 2026
- Reason
- Failed Dissolution Specifications
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0444-2026
- Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91
Terminated Class II Drugs
- Recall started
- 23 December 2024
- Terminated
- 12 November 2025
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
- Distribution
- USA nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0203-2025, D-0204-2025
- Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93
- Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93
Ongoing Class II Drugs
- Recall started
- 18 November 2024
- Reason
- Superpotent Drug and Subpotent Drug: potency failures obtained
- Distribution
- Nationwide within the United States and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0120-2025, D-0127-2025, D-0124-2025, D-0118-2025, D-0122-2025, D-0128-2025, D-0121-2025, D-0119-2025, D-0126-2025, D-0125-2025, D-0123-2025
- 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), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A
- 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), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A
- 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), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
- 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), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A
- 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), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A
- 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), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A
- 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), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A
- 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), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A
- and 3 more product lines
Completed Class II Drugs
- Recall started
- 30 April 2024
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0603-2024, D-0602-2024
- Cardura 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
- Cardura 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
Completed Class III Drugs
- Recall started
- 25 April 2024
- Reason
- Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
- Distribution
- Nationwide within the united states
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0481-2024
- Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77
Terminated Class II Drugs
- Recall started
- 25 May 2023
- Terminated
- 11 April 2024
- 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.
- Distribution
- Product was distributed to 10 distributors who may have further distribute the product to the retail level.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0866-2023
- Levsin 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 0087
Terminated Class II Drugs
- Recall started
- 21 October 2022
- Terminated
- 13 July 2023
- Reason
- Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0063-2023
- Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05
Terminated Class I Drugs
- Recall started
- 7 October 2022
- Terminated
- 12 January 2024
- Reason
- Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0058-2023
- Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, ND
Terminated Class II Drugs
- Recall started
- 21 September 2022
- Terminated
- 31 October 2023
- Reason
- Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1542-2022
- 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 Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 U.S.A
Terminated Class II Drugs
- Recall started
- 28 April 2022
- Terminated
- 21 June 2023
- Reason
- Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
- Distribution
- Product was distributed nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0844-2022
- alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.
Terminated Class II Drugs
- Recall started
- 28 April 2022
- Terminated
- 13 July 2023
- Reason
- Failed Dissolution Specifications: low out of specification results for dissolution.
- Distribution
- Product was distributed nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0854-2022
- Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.
Terminated Class III Drugs
- Recall started
- 13 September 2021
- Terminated
- 28 April 2022
- Reason
- Failed Impurities/Degradation Specifications; out of specification for Related Compound
- Distribution
- Product was distributed nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0798-2021
- Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93
Terminated Class II Drugs
- Recall started
- 23 August 2021
- Terminated
- 7 September 2022
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0851-2021
- Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.