Drug FDA Class III Ongoing Foreign material

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.

Macleods Pharmaceuticals Ltd Published Jul 16, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Macleods Pharmaceuticals Ltd or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Hazards

Hair Strand · primary

Affected products (1)

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.

FAMCICLOVIR · 9,888/ 30 count bottles

NDC: 33342-024, 33342-025, 33342-026, 33342-024-07, 33342-025-07, 33342-026-07

Lot codes: 12250247B

Code info: Lot # 12250247B, Exp. 01/31/2027

Affected areas

Nationwide

Timeline

Initiated

Jun 11, 2025
Published

Jul 16, 2025

Recall number: D-0509-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.