Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by
Summary
The FDA issued a Class III for Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Ma by Macleods Pharmaceuticals Ltd. Reason: Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle..
Details
Source
Drug Recall
External ID
D-0509-2025
Action Date
2025-07-16
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot # 12250247B, Exp. 01/31/2027
Quantity Affected: 9,888/ 30 count bottles
Reason for Recall
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Distribution
U.S. Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-11
Company
Mumbai, N/A
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 89 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Macleods Pharmaceuticals Ltd has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Macleods Pharmaceuticals Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Macleods Pharmaceuticals Ltd have FDA actions?
Macleods Pharmaceuticals Ltd has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0509-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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