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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94482

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 25, 2024
Product types
Drug
Classifications
Class III
Statuses
Completed
Recalling firm wording
Viatris Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77

D-0481-2024
Recall number
D-0481-2024
Initiated
April 25, 2024
Classification
Class III
Status
Completed
Recalling firm
Viatris Inc
Quantity
143,230 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 3183269, Exp. Date May 2025; 3157326, Exp. date June 2024

Distribution pattern

Nationwide within the united states