FDA recall D-0509-2025

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.

Reason for recall

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

Distribution

U.S. Nationwide.

Key facts

Status

Ongoing

Initiation date

2025-06-11

Report date

2025-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mumbai, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0509-2025