Reported Jul 16, 2025 · Ongoing

Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured…

Macleods Pharmaceuticals Ltd.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Macleods Pharmaceuticals Ltd · 304 Atlanta Arcade · Mumbai, N/A · N/A

Is this the product you have?

  • Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only
  • Manufactured forMacleods Pharma USA, Inc
  • Manufactured byMacleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07
Lot codes and dates
    • Lot # 12250247B
    • Exp. 01/31/2027
Amount recalled
9,888/ 30 count bottles

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:06 PM UTC

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