FDA Drug recall D-0481-2024
Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc
- FDA Drug
- Class III
- completed
- Published 2024-05-08
On 2024-05-08 the FDA classified a Class III recall of Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc by Viatris, citing failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0481-2024 |
| Classification | Class III |
| Status | completed |
| Initiated | 2024-04-25 |
| Published | 2024-05-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Viatris |
| Distribution | US |
Product
Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77
Reason
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Identifiers
| ndc | 0378-4275-93 |
|---|---|
| ndc | 0378-4275-77 |
| ndc | 0378-4276-93 |
| ndc | 0378-4276-77 |
| code_info | Lot #: 3183269, Exp. Date May 2025; 3157326, Exp. date June 2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
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FDA Drug · Class II · 2024-12-18 · Viatris - 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
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0481-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.