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D-0509-2025Class III

Macleods Pharmaceuticals Ltd

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Macleods Pharmaceuticals Ltd
Product type
Drug
Status
Ongoing
Report date
2025-07-16
Distribution
U.S. Nationwide.
Firm state
N/A
Product quantity
9,888/ 30 count bottles
Initiated by
Voluntary: Firm initiated
Reason for recall

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

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.

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →