Recall Register

Food, drugs, devices › Firms

Viatris, Inc.

FDA recalling firm · 11 enforcement events · 23 product records · 2022–2026 · PA

Viatris, Inc. has 11 FDA enforcement events on this register (23 product records) between 2022 and 2026: 11 drug; the busiest year was 2022 with 5.

9% of its events are Class I; the most common class is Class II (9). 2 events are listed as ongoing; the recalling firm's address is in PA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
17 Mar 2026Xanax 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 58151-506-91DrugClass II1Ongoing
23 Dec 2024Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93DrugClass II2Terminated
18 Nov 2024Levothyroxine 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.DrugClass II11Ongoing
30 Apr 2024Cardura 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 0049-2040-10DrugClass II2Completed
25 Apr 2024Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77DrugClass III1Completed
25 May 2023Levsin 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 #0037-9001-05DrugClass II1Terminated
21 Oct 2022Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05DrugClass II1Terminated
7 Oct 2022Octreotide 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, NDC: 67457-246-00 (syringe), 67457-246-01 (carton).DrugClass I1Terminated
21 Sep 2022Ampicillin 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.ADrugClass II1Terminated
28 Apr 2022Xanax 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.DrugClass II1Terminated
28 Apr 2022alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.DrugClass II1Terminated

By type and class

Drug11
Class II9
Class I1
Class III1

Class I: 9% of this firm's events; 18% of all events on the register.

Events by year

22
23
24
25
26
Enforcement events for Viatris, Inc. by year initiated.

Questions and answers

How many FDA recalls has Viatris, Inc. had?

11 enforcement events (23 product records) on this register, 2022–2026: 11 drug.

Are any Viatris, Inc. recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are Viatris, Inc. recalls?

9 Class II, 1 Class I, 1 Class III. 9% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.