Famciclovir Tablets — Class III drug recall D-0509-2025
Ongoing recall by Macleods Pharmaceuticals Ltd, reported 2025-07-16, distributed nationwide. Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
| Recall number | D-0509-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macleods Pharmaceuticals Ltd, Mumbai, N/A, India |
| Recall initiated | 2025-06-11 |
| Classified | 2025-07-07 |
| Reported by FDA | 2025-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 9,888 |
| NDC | 33342-0024, 33342-0024-07, 33342-0025, 33342-0025-07, 33342-0026, 33342-0026-07 |
| Lot numbers | 12250247B |
| Expiration dates | 2027-01-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0509-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.