Recalls / Class III
Class IIID-0509-2025
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.
- Brand name
- Famciclovir
- Generic name
- Famciclovir
- Active ingredient
- Famciclovir
- Route
- Oral
- NDCs
- 33342-024, 33342-025, 33342-026
- FDA application
- ANDA201022
- Affected lot / code info
- Lot # 12250247B, Exp. 01/31/2027
Why it was recalled
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Recalling firm
- Firm
- Macleods Pharmaceuticals Ltd
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 304 Atlanta Arcade, Church Road, Mumbai, N/A N/A, India
Distribution
- Quantity
- 9,888/ 30 count bottles
- Distribution pattern
- U.S. Nationwide.
Timeline
- Recall initiated
- 2025-06-11
- FDA classified
- 2025-07-07
- Posted by FDA
- 2025-07-16
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0509-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.