Recall
FDAHealthJune 11, 2025

Macleods Pharmaceuticals Ltd — Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
June 11, 2025

U.S. Nationwide.

What's affected?

Product
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.
UPC
0333342026071
Lot code
12250247B

Additional details

Lot # 12250247B, Exp. 01/31/2027

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 9,888/ 30 count bottles.

View original FDA notice →

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