Macleods Pharmaceuticals Ltd: Drug Recall

Recall #D-0509-2025 · 06/11/2025

Class III: Low Risk

Recall Details

Recall Number
D-0509-2025
Classification
Class III
Product Type
Drug
Recalling Firm
Macleods Pharmaceuticals Ltd
Status
Ongoing
Date Initiated
06/11/2025
Location
Mumbai, N/A, India
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9,888/ 30 count bottles

Reason for Recall

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

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.

Distribution Pattern

U.S. Nationwide.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.