Recall: D-0509-2025

Class III - Minor Violations

Class IIIClassification

2025-06-11Initiated

OngoingStatus

Macleods Pharmaceuticals LtdFirm

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

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

Distribution

U.S. Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.