Prescription Valacyclovir Tablets Recalled Due to Missing Imprint
Viatris Inc is recalling 143,230 bottles of Valacyclovir Hydrochloride 500 mg tablets due to missing imprints on some tablets. The recall is nationwide and affects two lot numbers expiring in June 2024 and May 2025.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall involving missing tablet imprints with no reported illnesses or injuries. Missing imprints are labeling defects affecting medication identification, qualifying as Moderate rather than Low per the rubric.
Plain-English summary
Viatris Inc is recalling Valacyclovir Hydrochloride tablets, 500 mg, nationwide due to a labeling defect. The recall involves 143,230 bottles from two lot numbers: 3183269 (expiration May 2025) and 3157326 (expiration June 2024).
The defect is that some tablets in the affected lots are missing the printed imprint 'M 122,' which serves as an identifier for the medication. This could prevent patients from properly verifying their medication.
If you have a bottle of Valacyclovir Hydrochloride with one of the affected lot numbers, contact your pharmacist or healthcare provider. They can assist you in confirming your medication and determining next steps.
The recalled product
- Product
- VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR)
- Brand
- VALACYCLOVIR HYDROCHLORIDE
- Manufacturer
- Viatris Inc
- Category
- Drug — Prescription Antiviral
- Hazard
- Affected units
- 143,230
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 3183269
- Exp. Date May 2025
- 3157326
- Exp. date June 2024
UPCs (2)
- 0303784276938
- 0303784275931
Distribution
Distributed nationwide across the United States.
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