Valacyclovir Tablets USP — Class III drug recall D-0481-2024
Completed recall by Viatris Inc, reported 2024-05-08, distributed nationwide. Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some table
| Recall number | D-0481-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viatris Inc, Canonsburg, PA, United States |
| Recall initiated | 2024-04-25 |
| Classified | 2024-05-02 |
| Reported by FDA | 2024-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 143,230 bottles |
| NDC | 00378-4275, 00378-4275-77, 00378-4275-93, 00378-4276, 00378-4276-77, 00378-4276-93 |
| Lot numbers | 3157326, 3183269 |
| Expiration dates | 2024-06-20, 2025-05-20 |
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 for recall
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0481-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.