Home / Recalls / Macleods Pharmaceuticals Ltd / D-0509-2025

D-0509-2025 Class III Ongoing

Recalled by Macleods Pharmaceuticals Ltd — Mumbai, N/A

Recall Details

Product Type: Drugs
Report Date: July 16, 2025
Initiation Date: June 11, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9,888/ 30 count bottles

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.

Reason for Recall

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

Distribution Pattern

U.S. Nationwide.

Code Information

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