Famciclovir Tablet, Film Coated
FDA Recall NDC 33342-024
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Famciclovir (NDC 33342-024). A significant event, classified as Class III, was initiated on Jun 11, 2025 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
June 2025 Class III Recall: Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Recall Number
Class III Ongoing
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Jun 11, 2025
Jul 16, 2025
9,888/ 30 count bottles
Recall Profile & Regulatory Data
Event ID
97058
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Macleods Pharmaceuticals Ltd
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide.
Product Description
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.
Batch or Lot Expiration Information
Lot# 12250247B, Exp. 01/31/2027
Affected Packages Involved in this Recall
33342-024-07Product
33342-025-07Product
33342-026-07Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
