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Class III · Lower riskRecall completed

Valacyclovir Hydrochloride

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: 3183269, Exp. Date May 2025; 3157326, Exp. date June 2024
Where it was soldNationwide within the united states
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMylan Pharmaceuticals Inc.
Brand nameVALACYCLOVIR HYDROCHLORIDE
Generic nameVALACYCLOVIR
Active ingredient(s)VALACYCLOVIR HYDROCHLORIDE
Distributed by / forMylan Pharmaceuticals Inc. Morgantown, WV 26505 USA
NDC0378-4275-77
Show the full FDA record
Full product labelValacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77
Recalling firmViatris Inc
DistributionNationwide within the united states
Quantity143,230 bottles
Recall initiated2024-04-25
Report date2024-05-08
Recall completed—
Recall numberD-0481-2024
ClassificationClass III
FDA statusCompleted
Origin on fileCanonsburg PA United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.