Drug & medication recalls

Macleods Pharmaceuticals Ltd recalls Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured b…

Recall date
June 11, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0509-2025
FDA classification
Class III
Brand / firm
Macleods Pharmaceuticals Ltd
Sold / distributed
U.S. Nationwide.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What 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.

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