The Recall Desk
HighFDA (Drugs)·D-0509-2025·Announced 2025-07-16

[pending] FAMCICLOVIR (FAMCICLOVIR)

Pending LLM rewrite. Source: FDA_DRUG D-0509-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

Product
FAMCICLOVIR (FAMCICLOVIR)
Brand
FAMCICLOVIR
Manufacturer
Macleods Pharmaceuticals Ltd

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 12250247B
  • Exp. 01/31/2027

UPCs (3)

  • 0333342026071
  • 0333342024077
  • 0333342025074

Distribution

Distributed nationwide across the United States.