Valacyclovir Tablets USP recall
FDA recall D-0481-2024 · initiated Apr 25, 2024
Viatris Inc recalled Valacyclovir Tablets USP in Apr 2024 — an FDA Class III recall (D-0481-2024) because Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 143,230 bottles
Details
- Product
- Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77
- Recalling company
- Viatris
- Classification
- Class III
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the united states
- Initiated
- Apr 25, 2024
- FDA report date
- May 8, 2024
Frequently asked
- Was Valacyclovir Tablets USP recalled?
- Viatris Inc recalled Valacyclovir Tablets USP in Apr 2024 — an FDA Class III recall (D-0481-2024) because Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Valacyclovir Tablets USP recalled?
- Per the FDA enforcement record, the reason for recall D-0481-2024 was: Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
- Is a recalled Valacyclovir Tablets USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Valacyclovir Tablets USP are affected?
- Distributed: Nationwide within the united states. The recall covers these lots — Lot #: 3183269, Exp. Date May 2025; 3157326, Exp. date June 2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0481-2024.