FDA Drugs recall ·
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only… recall
- Recall number
- D-0509-2025
- Date
- (initiated June 11, 2025)
- Company / brand
- Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Mumbai, N/A, India - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 9,888/ 30 count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 12250247B, Exp. 01/31/2027
Distribution
U.S. Nationwide.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0509-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.