PlainRecalls
FDA Drug Low Class III Ongoing

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.

Reported: July 16, 2025 Initiated: June 11, 2025 #D-0509-2025

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.

Details

Units Affected
9,888/ 30 count bottles
Distribution
U.S. Nationwide.
Location
Mumbai, N/A

Frequently Asked Questions

What product was recalled?
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.. Recalled by Macleods Pharmaceuticals Ltd. Units affected: 9,888/ 30 count bottles.
Why was this product recalled?
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 16, 2025. Severity: Low. Recall number: D-0509-2025.