CLASS III Drug recall · Reported 8 May 2024 · FDA Enforcement Report
Valacyclovir Tablets USP, 500 mg recalled by Viatris
Viatris is recalling Valacyclovir Tablets USP, 500 mg, distributed nationwide in the US. The recall was initiated on 25 Apr 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0481-2024
- FDA event ID
- 94482
- Recalling firm
- Viatris, Canonsburg, PA
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Classification
- Class III
- Status
- Completed
- Recall initiated
- 25 Apr 2024
- FDA classified
- 2 May 2024
- Reported
- 8 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 25 Apr 2024 | Recall initiated by company | |
| 2 May 2024 | Classified by FDA | +7 days |
| 8 May 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Product as listed by the FDA
Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77
Where it was distributed
Nationwide within the united states
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Which lots are affected?
Lot #: 3183269, Exp. Date May 2025; 3157326, Exp. date June 2024
Where was it sold?
Nationwide within the united states
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Valacyclovir recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Valacyclovir Tablets recalled by Hetero Labs Limited Unit VValacyclovir | Hetero Labs Limited Unit V | Temperature Abuse | Nationwide |
| Drug | CLASS II | Valacyclovir Hydrochloride Tablets recalled by Teva Pharmaceuticals USA | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Valacyclovir HCl Tablets, 500 mg blister cards recalled | American Health Packaging | Potency & Assay | Nationwide |