Medications & Supplements/Prescription Drugs

Mylan Valacyclovir 500 mg Tablets Recalled for Missing 'M 122' Imprint

Agency Publication Date: May 2, 2024

Summary

Viatris Inc (formerly Mylan Pharmaceuticals) is recalling 143,230 bottles of Valacyclovir (valacyclovir) 500 mg tablets because some tablets may be missing the required 'M 122' identification imprint. This recall involves 90-count bottles of prescription medication distributed nationwide across the United States. Without the proper imprint, it may be difficult for patients or caregivers to correctly identify the medication once it is removed from the bottle.

Risk

The missing tablet imprint poses a low health risk, but it could lead to potential medication errors or confusion for consumers who rely on tablet markings to distinguish between different prescriptions.

What You Should Do

This recall involves 90-count bottles of Valacyclovir Tablets USP, 500 mg, sold under the Mylan Pharmaceuticals label (NDC 0378-4275-77).
Check your prescription bottle for lot numbers 3183269 (Expiration May 2025) or 3157326 (Expiration June 2024). Individual tablets should normally have 'M 122' imprinted on them; the recalled tablets may be blank.
If you have health concerns about your medication, contact your healthcare provider or pharmacist.
Return any unused product to the place of purchase for a refund, throw it away, or contact Viatris Inc for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Valacyclovir Tablets USP (90 count bottles)

Variants: 500 mg, Tablet

Lot Numbers:

3183269 (Exp May 2025)

3157326 (Exp June 2024)

NDC:

0378-4275-77

Manufactured for Mylan Pharmaceuticals Inc. Prescription Only (Rx Only).

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94482

Status: Resolved

Manufacturer: Viatris Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 143,230 bottles

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves 90-count bottles of Valacyclovir Tablets USP, 500 mg, sold under the Mylan Pharmaceuticals label (NDC 0378-4275-77).

Check your prescription bottle for lot numbers 3183269 (Expiration May 2025) or 3157326 (Expiration June 2024). Individual tablets should normally have 'M 122' imprinted on them; the recalled tablets may be blank.

If you have health concerns about your medication, contact your healthcare provider or pharmacist.

Return any unused product to the place of purchase for a refund, throw it away, or contact Viatris Inc for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.