FDA Recall D-0509-2025
Macleods Pharmaceuticals Ltd · Mumbai, N/A
Class III Ongoing 337 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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.
Reason for recall
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Recall record
- Recall number
D-0509-2025- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S. Nationwide.
- Recall initiated
- 2025-06-11
- Classified by FDA Center
- 2025-07-07
- FDA published
- 2025-07-16
- Recalling firm
- Macleods Pharmaceuticals Ltd
- Firm location
- Mumbai, N/A, India
Drug identification
- Brand name(s)
- FAMCICLOVIR
- Generic name(s)
- FAMCICLOVIR
- Manufacturer(s)
- Macleods Pharmaceuticals Limited
- NDC(s)
33342-024, 33342-025, 33342-026- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.