June 2025 FDA Recall Famciclovir by Macleods Pharmaceuticals Ltd
D-0509-2025 - Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
This Class III drug recall was voluntarily initiated by Macleods Pharmaceuticals Ltd on June 11, 2025 for the product Famciclovir. The FDA reported the reason for recall as presence of foreign substance- black hair strand found attached to a tablet in a sealed bottle.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0509-2025
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
06-11-2025
07-16-2025
9,888/ 30 count bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Macleods Pharmaceuticals Ltd
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# 12250247B, Exp. 01/31/2027
